https://doi.org/10.1002/14651858.CD010216.pub11
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Study name |
HARMONY: HARM reduction for Opiates, Nicotine and You |
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Methods |
Design: randomized, single-blinded, parallel-group trial |
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Participants |
Inclusion criteria: written, informed consent; 18 to 65 years; accessing opioid agonist treatment from a participating service; current daily tobacco smokers on self-report; want to quit or cut down their tobacco smoking; willing and able to comply with requirements of study (including having access to a phone) Exclusion criteria: breastfeeding or pregnant; severe medical disorder assessed by study medical officer (such as, but not limited to, unstable cardiovascular/peripheral vascular disease, poorly controlled hypertension); severe and unstable psychiatric disorder assessed by study medical officer (such as, but not limited to, acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others); current enrolment in a clinical trial involving any investigational drug; gular use (more than one day per week) of VNP or EC containing nicotine in the last 30 days; not available for FU Motivated to quit |
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Interventions |
Comparison of a 12-week course of liquid nicotine delivered via EC or Vaporised Nicotine Product (VNP) to best practice Nicotine Replacement Therapy (NRT) Condition 1: EC (VNP) (Innokin Endura T18‐II starter kit) • Device loaded with one bottle of 12 mg/mL e-liquid • An additional seven (7) bottles of 12 mg/mL e-liquid • A brief information session on how to use the VNP • A VNP information pack including safe storage of e-liquid nicotine and disposal • 1-week supply of nicotine patches • Training on the use of NRT patches • Where possible, ensure that participant uses the VNP before leaving and leaves wearing an NRT patch. Adherence will be measured via questionnaires. In addition to the VNP, liquid nicotine and NRT patches, participants will be shown the New Zealand website vapingfacts.health.nz/ and encouraged to visit the site as an online resource throughout the trial. Participants will also receive training in the forms of brief videos, information pamphlets, user manuals and interactive discussions with research staff. |
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Outcomes |
Baseline, 12, 24 weeks Primary outcome: self-reported 7-day PPA from tobacco smoking assessed in the following dichotomous question “In the last 7 days, have you smoked a cigarette, even a puff?" (Week 12) Secondary outcome: a cost consequence study setting out detailed comparative costs of treatments - from the perspective of healthcare provider and primary and secondary outcomes of the VNP and NRT Adverse events recorded Biochemically verified PPA: this will be measured via a CO monitor breath test for participants who self-report 7-day PPA at end of treatment (Week 12) Changes in nicotine craving and withdrawal symptoms |
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Starting date |
Registered Feb 2021. Record updated Jan 2024. |
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Contact information |
Adrian Dunlop, adrian.dunlop@health.nsw.gov.au |
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Study name |
Puff vs Pill: break the Habit Study: effect of Nicotine Vaping Products vs Varenicline on Smoking Cessation Among People Experiencing Social Disadvantage |
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Methods |
RCT |
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Participants |
Target N = 872 Inclusion: Aged 18 years or older; Receiving a government pension, support, or allowance (proxy for low-SES)*; Person who currently smokes tobacco daily** and wanting to quit tobacco smoking; Willing to use varenicline or NVPs in next quit attempt; Willing to make a quit attempt on designated quit day (~8-14 days post-randomisation); Exclusion: Pregnant / breast-feeding; participation in another quit smoking program or study, or previously enrolled in this study; Current use of any quit smoking medications or products (i.e., NRT, bupropion [Zyban], varenicline [Varenapix], cytisine, NVPs/ e-cigarettes containing nicotine, nicotine inhalers or any other quit smoking medications or products); Allergies or hypersensitivity to either varenicline or nicotine-containing e-liquids, or any excipients; End stage or severe renal diseased; Deemed medically unfit. Population: low SES EC use at baseline: no Willing to quit CC: yes |
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Interventions |
Arm 1. EC / Nicotine vaping products (NVPs) in the form of two “pod” devices either prefilled [Alt] and refillable [Rift] with nicotine salt e-liquids containing nicotine (4%;40mg/ml) in tobacco or mint flavours for 12 weeks. For each device a USB charger will be provided, as well as a shared wall adaptor. Participants will be provided with detailed instructions on how to use the vaping products, along with a wallet card and fridge magnet with product use and safety information for quick access. Participants are advised to use the study product ad libitum throughout the day to either mitigate or satiate the urge to smoke tobacco products. They are encouraged to stop using the devices once they no longer feel the urge to smoke. Arm 2. Varenicline |
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Outcomes |
Baseline, 12 months Carbon monoxide (CO) verified 6-month continuous abstinence at 12-month follow-up. [Only participants self-reporting continuous abstinence from smoking tobacco at final follow-up will be biochemically verified]. Bedfont iCO Smokerlyzer®, or administered by a trained researcher using a hand-held Micro+™ Smokerlyzer® with a disposable, one-use mouthpiece. CO level of less-than-or-equal-to 5 parts per million will be considered abstinent. Change in number of cigarettes smoked from baseline to final follow up at 12 months Self-reported AEs and SAEs. Use of varenicline or NVP at final follow up Change in self-reported respiratory symptoms.[ Modified Medical Research Council (MRC) dyspnoea scale Participants’ treatment adherence and compliance. Self-reported: 7-day point prevalence abstinence; and continuous abstinence for 6 months Change in self-reported respiratory symptoms |
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Starting date |
Registered 14 February 2025. |
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Contact information |
Ryan Courtney, National Drug and Alcohol Research Centre, The University of New South Wales, Sydney NSW 2052 Australia. r.courtney@unsw.edu.au |
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Notes |
Added as ongoing study 2025. |
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Study name |
Randomized, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol |
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Methods |
3-arm, randomized, placebo-controlled, multicentre, double-blind, double-dummy, parallel-group phase III type trial Setting: smoking cessation clinics of both academic and community hospitals Recruitment is either local (a) directly by the centres or centralized (b) using a web page and a centralized study-specific phone number and email address.
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Participants |
Estimated enrolment: 650 participants Inclusion criteria: people who smoke, ≥ 10 CPD (factory-made or roll-your-own) in the past year; aged 18 to 70; motivated to quit, defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated); informed consent; understanding and speaking French; women of childbearing age can be included if they use an effective contraceptive method: either hormonal contraception or an intrauterine device started at least 1 month before the first research visit; individual affiliated to a health insurance system; previous failure of NRT for smoking cessation Exclusion criteria: any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments, such as recent myocardial infarction, unstable or worsening angina, severe cardiac arrhythmia, unstable or uncontrolled arterial hypertension, recent stroke, cerebrovascular disease, obliterative peripheral arterial disease, cardiac insufficiency, diabetes, hyperthyroidism, pheochromocytoma, severe hepatic insufficiency, history of seizures, severe depression, COPD; any life-threatening condition with life expectancy of < 3 months; alcohol use disorder defined as a score ≥ 10 on the Alcohol Use Disorders Identification Test (AUDIT)-C questionnaire; abuse of or dependence on illegal drugs in the last 6 months, revealed by medical history; regular use of tobacco products other than cigarettes; current or previous (last 6 months) use of EC; pregnancy/breastfeeding; protected adults; current or past 3 months participation in another interventional research; current or past 3 months use of smoking cessation medication such as varenicline, bupropion, NRTs; known lactose intolerance (placebo tablets contain lactose); hypersensitivity to the active substance or to any of the excipients; known severe renal failure |
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Interventions |
A) EC without nicotine (ECwoN) plus placebo tablets of varenicline (0.50 mg) administered by oral route: placebo condition B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. C) Reference: ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorization E-cigarette details:
Behavioural support:
Treatment duration: 1 week + 3 months |
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Outcomes |
Week 2, 4, 8, 10, 12, 24 after target quit day Primary outcome:
Secondary outcomes:
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Starting date |
17 October 2018. Trial suspended (March 2025) due to unavailabilty of varenicline. Due to re-start as soon as varenicline is available. |
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Contact information |
Ivan Berlin, ivan.berlin@aphp.fr |
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Study name |
Preference-based tools for smoking cessation among disadvantaged smokers, a pragmatic randomised controlled trial (STOP) |
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Methods |
RCT France |
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Participants |
Actual enrollment: 167. Estimated enrolment: 528. Inclusion criteria: daily smokers (≥ 5 cigarettes/day); low socioeconomic position; available for at least 4 appointments over a 6-month period; affiliation to or benefiting from social security or state medical support Exclusion criteria: individuals who do not speak French; major citizens protected by law, adults unable to express their consent; pregnant women; regular smokers who vape daily (at least once a day) |
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Interventions |
EC: type not stated Arm 1: The STOP intervention Assisting smokers with low socioeconomic position in their smoking cessation attempt. Routine care and adapted advice supplemented with a free delivery of any or several type(s) of nicotine replacement therapy (NRT) (patches, inhalers, gum, tablets, etc.) and/or an e-cigarette + e-liquid, based on the smokers' preference and choice Arm 2: Standard care Participants randomised to the standard care group will be given standard care in assisting their smoking cessation attempt, but without free delivery of NRT or e-cigarettes. Standard care includes motivational interviewing, advice to quit, and prescription for NRTs. |
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Outcomes |
Smoking abstinence at 6 months after inclusion Total number of days of abstinence at 6 months Smoking abstinence at 1 and 3 months after inclusion Number of relapses; CPD; proportion of participants who have significantly reduced daily smoking |
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Starting date |
Start date: 26 February 2021. Study completion date: 30 August 2024 (final data collection date for primary outcome measure). |
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Contact information |
Fabienne El-Khoury, Institut National de la Santé Et de la Recherche Médicale, France |
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Notes |
New to 2022 update |
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Study name |
Acceptability of a telehealth smoking harm reduction intervention using e-cigarettes among cigarette smokers with opioid use disorder: a qualitative analysis |
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Methods |
RCT |
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Participants |
Number not stated. 12% female. Average age of 55 years (Range: 39-69). Eligibility: smoke at least 5 CCs per day; 21 years or older; enrolled in an OUD treatment program for at least 12 weeks; and were interested in reducing CC smoking Participants in treatment programs for opioid use disorders (OUD) Motivation to quit: 'interested in reducing CC' |
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Interventions |
1. EC. Vuse EC and tobacco flavored cartridges, manufactured by RJ Reynolds. Harm reduction counseling (up to 5 sessions). Encouraged to switch from CC to EC. 2. NRT (no detail on form of NRT provided). Harm reduction counseling (up to 5 sessions). Description of counseling for both arms: telehealth session (20-25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation, delivered via WebEx (Web conferencing platform, Cisco, San Jose, CA, USA) or phone, based on participant preference). Up to 4 additional sessions were delivered (with target scheduling on weeks 2, 3, 4, and 6), 15 to 20 minutes each. Participants were compensated for their time during the research visits |
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Outcomes |
Counseling delivered initial session and weeks 2, 3, 4, and 6. Paper reports feasibility and acceptability of using EC for the EC arm. "This was a qualitative study embedded within a feasibility randomized-controlled trial, the results of which will be published in the future." |
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Starting date |
Qualitative interviews were conducted from March to May 2021. |
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Contact information |
Omar Elshahawy, omar.elshahawy@nyulangone.org |
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Notes |
Funding: This work was supported by the New York State Empire Clinical Research Investigator Program and NIH/NIDA R01DA055675 (El-Shahawy). The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Added as ongoing to 2026 update. |
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Study name |
Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial |
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Methods |
RCT Setting: Pakistan Recruitment centres in 2 metropolitan districts: Islamabad and Rawalpindi |
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Participants |
Estimated enrolment: 600 EC + counselling: estimated 200 Nicotine pouches + counselling: estimated 200 Counselling: estimated 200 Inclusion criteria: > 18; > 10 CPD; CC use for > 1 year; willing to stop CC use; sign a written consent form; 1 applicant per household; phone Exclusion criteria: pregnant; childbearing mothers; using other nicotine- and non-nicotine-based cessation therapies; chest pain, or another cardiovascular event or procedure (e.g. heart attack, stroke, insertion of stent, bypass surgery) Motivated to quit |
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Interventions |
Provision of EC or nicotine pouches for 48 weeks 3 groups:
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Outcomes |
Baseline, 12, 24, 36, 48 weeks. 60 weeks FU. AEs CPD Self-reported point-prevalence abstinence from CC in the previous week with biochemical validation will be used (exhaled carbon monoxide less than 10 parts per million (PPM)) 7-day point-prevalence abstinence from CC (at all subsequent check-ups) (biochemically validated at weeks 12, 24, 36, 48, and 60) Harm-reduction effect of e-cigarettes and nicotine pouches |
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Starting date |
Estimated starting date: December 2023 Estimated completion date: April 2025 |
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Contact information |
Abdul Hameed, +923315813713, hameedleghari@gmail.com Daud Malik, +923028560310, daud31us@yahoo.com |
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Notes |
New to 2024 Funding: Foundation for a Smoke Free World INC. Funded by Philip Morris International. ClinicalTrials.gov NCT05715164 |
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Study name |
ENHANCE-D trial: Enhancing dental health advice |
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Methods |
Design: RCT A pragmatic, multicentre, definitive, open-label, 3-arm, parallel-group, individually randomized, controlled, superiority trial, comparing the clinical- and cost-effectiveness, and safety of enhanced smoking cessation interventions to usual care, and each other (with an internal pilot) Setting: 56 NHS primary dental care setting in England and Scotland. Newcastle Clinical Trials Unit, UK |
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Participants |
Estimated enrolment: 1460 participants, 455 periodontitis subgroup Adult regular tobacco smokers attending an NHS dental setting. Dental patients with or without gum disease Inclusion criteria: a basic periodontal examination completed within the last 3 months; ≥ 18 years; current smoker Exclusion criteria: pregnant or currently breastfeeding; enrolled in another interventional research trial; used quit-smoking aid or reduce/quit alcohol; phaeocromocytoma, uncontrolled hyperthyroidism, extensive dermatitis/skin disorder; hypersensitivity to nicotine or any component of the study products; taking: clozapine, olanzapine, theophylline or aminophylline |
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Interventions |
EC: EC starter kit. Stainless Steel Aspire PockeX e-cigarette, coil replacement pack, 3-pin plug, 10 x Halo standard 10ml e-liquids (4 flavour options available) Condition: smoking cessation in dental patients with or without gum disease Arm 1: E-cigarette (EC) starter kit with single-visit behavioural support (same behavioural intervention as the NRT group). Participants will be expected to source their own supply of e-liquid after the initial supply and advice will be given as to where to source suitable MHRA registered products. Duration will vary depending on use of EC. Arm 2. Nicotine Replacement Therapy (NRT): standard 12-week course of combination NRT with single-visit behavioural support including the offer of NRT. 12-week course of combination NRT (patch plus faster-acting form such as chewing gum or lozenge), in line with current recommendations. Duration will be 12 weeks if a participant wants to continue NRT after initial 4-week supply. Nicotine transdermal patches. Option 1: NiQuitin 7 mg, 14 mg, 21 mg (24-hour patch). Option 2: Nicorette invisi 10 mg, 15 mg, 25 mg (16-hour patch) Nicorette gum 2 mg, 4 mg. Nicorette lozenge 2 mg, 4 mg Arm 3. VBA: usual care (control) 1. VBA is usual care for smokers in dental settings usually following the 3As: Ask, Advise, Act technique. This will signpost participants to a GP, pharmacy or stop-smoking service (SSS). 2. Participants in the control group will be free to use NRT or ECs as they wish, but these will not be provided by the dental professional. 3. Conducted at baseline visit, only a 5-minute intervention All patients will be followed up for up to 12 months from baseline. |
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Outcomes |
6 months for periodontal health parameters and 12 months for smoking outcomes To compare smoking abstinence at 6 months of NRT and EC to usual care and to each other (all participants). Biochemically verified smoking abstinence at 6 months, carbon monoxide monitor. To compare the periodontal health at 6 months of NRT and EC interventions to usual care and to each other, for those with periodontitis at baseline. Percentage of periodontal sites at 6 months with PPD (Pocket Probing Depths) ≥ 5 mm AEs; oral health, and oral health QoL; to evaluate nicotine dependence, urges to smoke, withdrawal symptoms, and longer-term smoking abstinence (12 months); cost benefit. SES inequalities Expired air carbon monoxide (eCO). Continuous biochemically verified smoking abstinence at 12 months. Fagerstrom Test for Nicotine Dependence (FTND). Cigarette withdrawal symptoms are measured using Mood and Physical Symptoms Scale (MPSS). Oral Health Quality of Life Assessment (OHQoL-UK). Oral health is measured using number of teeth at baseline and 6 months. Health economic evaluation. |
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Starting date |
Protocol 2022 Study start date February 2022. Estimated completion date March 2025. |
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Contact information |
Dr Richard Holliday richard.holliday@newcastle.ac.uk Professor Elaine McColl, Newcastle University |
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Notes |
New to 2023 update |
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Study name |
Vaporized nicotine products (VNP) versus nicotine replacement therapy for tobacco smoking cessation among low-socioeconomic status smokers: a randomised controlled trial |
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Methods |
Design: RCT Recruitment: study advertisements across online and social media platforms such as Facebook advertisements. Participants in a recently completed clinical trial comparing cytisine versus varenicline for smoking cessation who consented to being contacted about future research and were receiving a government pension were also invited to take part. Setting: National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia |
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Participants |
Target N: 1058 Inclusion criteria: participants can be included if they meet the following criteria:
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Interventions |
Vaporized nicotine product (VNP) devices (1 tank device and 1 pod device) for 8 weeks plus 5-week Text Message behavioural quit Support (TMS) with the option to opt out at any stage if desired. Participants will receive a mix of quit-smoking support text messages with content including information on how to use the study products; coping with nicotine withdrawal symptoms; study progress updates; and motivational ‘feel good’ messages. A mix of text, emojis and links to resources such as videos, websites and Graphics Interchange Format (GIF) images, will be used throughout the TMS programme to promote engagement with the programme. Each device will be charged using the provided USB charger and wall adaptor. A replacement battery and replacement coils (5 pieces per pack) will also be provided. The VNP tank device used is the Innokin Endura T18 Personal Vaporizer, which has a refillable 2.5 mL tank for the e‐liquid (18 mg/mL nicotine). 3 e-liquid flavours will be provided: tobacco, menthol and a fruit flavour. The study will have 3 e-liquid suppliers to guarantee ongoing supply throughout the study: Lumo Liquid in 10 mL bottles; VAPO e-liquid in 30 mL bottles; and DashVapes e-liquid in 30 mL bottles. All e-liquids are 18 mg/mL in strength. Lumo Liquid ingredients are as follows (w/w): tobacco flavouring (1.19%), nicotine (1.60%), vegetable glycerine (24.56%), propylene glycol (73.24%); menthol flavouring (4.83%), nicotine (1.60%), vegetable glycerine (22.99%), propylene glycol (71.18%); strawberry flavouring (0.63%), nicotine (1.60%), vegetable glycerine (33.00%), propylene glycol (71.00%). VAPO e-liquid additional flavour ingredients are as follows (w/w): tobacco flavouring (25.88%), nicotine (17.25%), vegetable glycerine (36.53%), propylene glycol (20.34). |
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Outcomes |
Primary outcome: CO-verified 6-month continuous abstinence at 7-month follow-up. Continuous 6-month abstinence will be defined as having remained quit for 6 months (having smoked no more than 5 cigarettes in that time), and a CO level of ≤ 5 ppm. Depending on the participant's indicated preference, the CO breath test will be self-administered using a hand-held iCO™ Smokerlyzer® (using provided instructions), or administered by a trained researcher using a hand-held iCO™ Micro+™ Smokerlyzer® with a disposable, one-use mouthpiece. Both devices are non‐invasive and require the participant to blow air into the device for 15 seconds to measure their CO level. An exhaled CO level of ≤ 5 ppm will be considered abstinent. Secondary outcome: Change in financial stress (assessed using Index of Financial Stress) |
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Starting date |
Start date: 30 March 2021. Date last data collection 8 Dec 2022. |
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Contact information |
Dr Ryan Courtney, National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052 Australia, r.courtney@unsw.edu.au |
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Study name |
Could giving someone who smokes help to quit through a financial advice service make them more likely to quit than someone who does not get any support? Scientific title: Brief opportunistic smoking cessation advice for financially vulnerable Individuals accessing financial support: a randomised controlled trial. SAVINGS Setting: UK Recruitment from financial advice services like food banks, Job Centres, and Citizens Advice across England, Scotland, and Wales. |
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Methods |
RCT Two-arm parallel randomized controlled trial with embedded pilot phase economic and process evaluations |
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Participants |
Estimated: 1,538 Inclusion: 1. Adults aged 18 or over. 2. Currently receiving advice or support for financial difficulties by financial guidance services. 3. Self-reported daily tobacco smoking, regardless of motivation to quit smoking. 4. Able to give informed consent. 5. Able to provide details for follow-up purposes. Exclusion: 1. People using only smokeless tobacco, heated tobacco, shisha, cannabis, or non-tobacco nicotine products like e-cigarettes or nicotine pouches. People using these products alongside daily tobacco smoking will still be eligible. |
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Interventions |
Nicotine EC + brief smoking cessation advice vs usual care Arm 1: Opportunistic, very brief advice on smoking, including information on the best ways to quit and providing and referring participants to relevant support. A nicotine EC will be provided alongside information on behavioural support available, including free access to a stop smoking app if preferred. |
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Outcomes |
Baseline, 3 months, 9 months, 18 months. Primary outcomes 1. Biochemically validated four-week prolonged abstinence from tobacco at 12 weeks post-randomisation. Saliva samples will be tested for cotinine and/or anabasine dependent on the use of non-tobacco nicotine post-quit attempt. Secondary outcomes Estimate the intervention’s cost-effectiveness relative to usual care from the public sector perspective. This will be judged based on 4 outcome measures: Qualitative process evaluation. Audio-recorded interviews with about 30 participants and 20 financial services advisors about their experiences with the intervention. Conversation analysis of approximately 350 financial advice service sessions to identify if: the intervention is delivered as intended; common pitfalls which may hinder delivery; and how these might be best managed or avoided. Fidelity testing among approximately 100 control group consultations . |
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Starting date |
Date of first enrollment: 07/04/2026 Estimated completion 31/03/2029 |
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Contact information |
Nicola Lindson, nicola.lindson@phc.ox.ac.uk |
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Notes |
Funding: National Institute for Health and Care Research (NIHR) in the UK. New to 2026 update. |
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Study name |
E-cigarettes for smoking cessation and reduction in people with a mental illness, ESCAPE |
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Methods |
RCT, multicentre Setting: GP practice, hospital, England, UK Organisation: University of York Tees, Esk and Wear Valleys NHS Foundation Trust; Bradford District Care NHS Foundation Trust; Sheffield Clinical Commissioning Group Hq; Oxford NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; South West Yorkshire Partnership NHS Foundation Trust; Nottinghamshire Healthcare NHS Foundation Trust; Lancashire and South Cumbria NHS Foundation Trust; Norfolk and Suffolk NHS Foundation Trust; CRN North East and North Cumbria; CRN East of England; The Burns Practice Bennetthorpe; Conisborough Medical Practice Conisbrough, Doncaster; Woodstock Bower Surgery, Rotherham |
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Participants |
Target N = 616 Mental Health Trusts and GP practices mainly in Yorkshire (UK) Inclusion: adults (aged over 18 years) receiving treatment for a mental illness in primary or secondary care, who smoke regularly, willing to quit or reduce cigarette smoking Exclusion: inpatient admission in the last 3 months; currently using EC regularly (at least weekly); participating in other smoking cessation trials; receiving treatment for drug or alcohol use; Alzheimer’s disease or dementia; pregnant or breastfeeding |
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Interventions |
Group 1 EC: e-cigarette and e-liquid to use for 4 weeks in addition to the usual care they are receiving. EC starter kit, a 20 mg/mL strength DOTPRO e-cigarette starter kit (https://www.liberty-flights.co.uk/DOT-PRO/DOT-PRO-Vape-Kit/) will be offered in a choice of flavours. The starter kit containing a pod-based e-cigarette, a 4-week supply of refill pods and an information leaflet. Brief face-to-face consultation with a clinician, who will explain how to use the e-cigarette and provide information to enable participants to make positive changes to their smoking behaviour. Encouraged to set a quit date. Participants will be provided with an e-liquid supply for 4 weeks. Group 2, usual care: participants will receive care as usual but will receive an e-cigarette and some e-liquid at the end of the study at the 6-month follow-up. |
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Outcomes |
Baseline, 1, 6 months Questionnaire; CO monitor Primary outcome measure
Secondary outcome measures
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Starting date |
Study start date: March 2023 Estimated study end date: April 2025 |
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Contact information |
Dr Anna-Marie Marshall, a.marshall@york.ac.uk. Lion Shahab, Lion.shahab@ucl.ac.uk |
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Notes |
New to 2024 Funding: Yorkshire Cancer Research (UK). Was misattributed to ISRCTN17691451 in paper. The correct clinical registraction is ISRCTN14068059 as linked to here and stated in correction 10.1111/add.70115. |
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Study name |
Do e-cigarettes help smokers quit when not accompanied by intensive behavioural support? A multi-center randomized controlled trial |
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Methods |
RCT Setting: UK Multicentre. Participants will be recruited mainly from hospitals and GP practices across the UK by the Clinical Research Network. The study is being organized by Queen Mary University of London (QMUL). Researchers from QMUL will provide the study treatment and conduct follow-up calls. |
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Participants |
1170 people who smoke tobacco cigarettes Inclusion criteria:
Exclusion criteria:
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Interventions |
The study will aim to use a refillable EC that is similar to the type used in a previous EC trial (One Kit - Innokin, UK Ecig Store), and one that is compliant with UK regulations, and not produced by a tobacco company. |
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Outcomes |
Follow-up at 4 weeks, 6 months and 12 months. CO at 6 and 12 months Primary outcome measure: Sustained smoking cessation at 6 months post-TQD. This is measured by asking participants if they have smoked since their TQD at the 6-month follow-up. To be counted as a 'quitter', participants must report smoking no more than 5 cigarettes since 2 weeks post-TQD with no smoking in the previous week, validated by carbon monoxide (CO) reading of < 8 ppm. Participants lost to follow-up will be counted as smokers. Secondary outcome measures:
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Starting date |
Overall trial start date: 1 September 2020 Estimated completion date January 2025 |
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Contact information |
Dr Katie Myers Smith, katie.smith@qmul.ac.uk |
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Study name |
Effectiveness of electronic cigarettes compared with combination nicotine replacement therapy for smoking cessation in patients with chronic obstructive pulmonary disease and effect on lung health (ECAL Trial) |
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Methods |
Multicentre, two-arm randomized controlled trial with embedded cost-effectiveness and cohort analyses (Prevention, Efficacy) Setting: England, Scotland, UK Study to look at CC abstinence, COPD and respiratory outcomes |
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Participants |
Target sample size: 1250 Inclusion criteria: COPD diagnosis previously confirmed by post-bronchodilator spirometry (FEV1/FVC < 0.7), any GOLD stage; current smoker (= 5 cigarettes per day); motivated to stop smoking; aged 35 or over Exclusion criteria: unable to perform spirometry to a satisfactory standard (e.g. due to dementia, lack of teeth, lack of coordination or not having a good oral seal); unsuitable to participate in the trial (e.g. terminal illness, unable to give informed consent); unable to participate in behaviour support calls; severe angina or unstable cardiovascular disease; end stage kidney disease/cirrhosis of the liver; taking NRT, bupropion, varenicline or ECs to stop or reduce smoking; in another trial of smoking cessation or COPD treatment/management; COPD exacerbation or inpatient hospital stay within the last 8 weeks; contraindications to spirometry within the last 12 weeks – tuberculosis infection, cardiac infarction, retinal detachment or surgery on the chest, abdomen, brain, ears or eyes |
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Interventions |
EC + telephone support vs NRT + telephone support Intervention arm: Electronic Cigarettes (EC) - At the baseline visit, participants will be given an EC starter pack and an initial supply of e-liquid (up to 20 mg nicotine/mL). Participants will be provided with instructions on how to continue sourcing further supplies themselves from reputable vendors in their preferred nicotine strength and flavours. |
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Outcomes |
Baseline, 4, 26, 52 weeks Questionnaire, CO monitored. Study to look at CC abstinence, COPD and respiratory outcomes. Primary outcome Abstinence from smoking since target quit date (TQD) biochemically validated (exhaled CO < 8 ppm), defined in accordance with the Russell Standard. This will be measured with a questionnaire and exhaled carbon monoxide measurement at 52 weeks post-TQD. Secondary outcomes
Health economic outcomes:
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Starting date |
Study registered: October 2023. First enrolment March 2024. Estimated study completion: September 2025 |
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Contact information |
Amanda Farley, a.c.farley@bham.ac.uk Institute of Applied Health Research, University of Birmingham, UK |
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Notes |
New to 2024 update. Funding: National Institute for Health and Care Research |
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Study name |
Efficacy of Electronic Cigarettes vs Varenicline and Nicotine Chewing Gum as an Aid to Stop Smoking: A Randomized Clinical Trial ChiCTR2100048156 (Chinese Clinical Trial Registry) |
|
Methods |
RCT 3 arm open label, multicentre Setting: 7 sites in China. China-Japan Friendship Hospital (Beijing, China), Peking University Health Science Center (Beijing, China), Beijing Hospital (Beijing, China), Beijing Xiyuan Hospital (Beijing, China), Beijing Geriatric Hospital (Beijing, China), Beijing Dongzhimen Hospital (Beijing, China), and Wuhan Tongji Hospital (Wuhan, China) Recruitment: Participants were recruited via trial sites, local newspapers, community events, websites, and referrals from other medical institutions. Inclusion criteria: smoked at least 10 cigarettes per day for at least 5 years, had expired air carbon monoxide (CO) reading of 9 parts per million (ppm) or greater, were aged 25 to 45 years, and were motivated to stop smoking. Age group chosen: “Due to concerns about adverse events being more likely in older age groups, the sample was limited to adults aged 25 to 45 years. Caution is needed in generalizing the results to older smokers.” Exclusion criteria: pregnancy or breastfeeding, use of stop-smoking medication during the previous 30 days, ever used ECs for 7 days or longer, history of severe psychiatric illness, unwillingness to use study products, and current diagnosis of cancer or in remission from cancer for less than 1 year. |
|
Participants |
Total N = 1068 EC = 409; varenicline = 409; NRT = 250 33.5% female; mean age 33.9 (SD 3.1); mean CPD 16.0 (SD5.3); mean FTND 4.1 (SD 2.1) EC use at baseline: no Motivation to quit: 50.4% had made previous quit attempt; 49.6% had not made previous quit attempt |
|
Interventions |
1. EC arm. A cartridge-based EC product called RELX Wuxian (RELX Technology (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that)). Leaflet with product use instructions. Supplied for 12 weeks free. Choice of 3 flavours: mung bean, watermelon, and ice cream. Participants were instructed to use 30 mg/mL cartridges of their preferred flavour for the first 2 weeks and 50 mg/mL cartridges after that, but were asked to continue using 30 mg/mL or reverse to it if they did not like the higher strength. One cartridge was expected to last for 3 days. At the baseline session, 10 cartridges were provided, with an option to request additional supplies at 1-month and 2-month follow-ups (up to 30 cartridges altogether). Participants were instructed to start using their EC ad lib from the next day and stop smoking completely from their TQD onward. 2. Varenicline arm (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that). Supplied for 12 weeks free. Participants received a 12-week supply of varenicline (Chantix; Pfizer) and a leaflet with product use instructions. Participants were instructed to take varenicline, 0.5 mg, once per day for the first 3 days, followed by 0.5 mg twice a day for the next 4 days and 1 mg twice a day from day 8, as per the China Clinical Guidelines for Tobacco Cessation. The product was purchased from the manufacturers. Participants were instructed to start using varenicline from the next day and stop smoking completely from their TQD onward. 3. NRT arm: nicotine chewing gum 2 mg (for smokers of 20 cigarettes per day) or 4 mg (> 20 cigarettes per day). Supplied for 12 weeks free Participants received a 12-week supply of nicotine chewing gum (Johnson & Johnson) product use instruction leaflet. Nicotine gum was selected as the most widely used form of NRT in China. Three boxes containing 105 pieces of the gum each were provided at each monthly contact, with an option to request additional supplies if needed. Participants who smoked up to 20 cigarettes per day received 2 mg nicotine gum, those smoking 20 or more cigarettes per day received 4 mg nicotine gum. Both strengths were provided with the fresh mint flavour. Supplies were bought from the manufacturer. Participants were instructed to use 8 to 12 pieces per day during the first 6 weeks, 4 to 8 pieces per day during weeks 7 and 8, and 2 to 4 pieces per day during the final 4 weeks, asper China Clinical Guidelines for Tobacco Cessation. Participants were instructed to use their NRT from the next day and stop smoking completely from the TQD onward. All groups: At the 3-month visit, participants were told that they could continue to use their products as needed, but would have to purchase them themselves. A leaflet was provided with information on where the products could be bought. At the last visit, participants received a $60 shopping voucher. All groups: accompanied by minimal behavioural support (an invitation to join a self-help internet forum). WeChat group for motivational support All participants set up their target quit date (TQD), normally 2 weeks after the baseline visit. All participants received a $40 shopping voucher as compensation for their time and travel. The baseline visit took approximately 30 to 45 minutes. At the last visit, participants received a $60 shopping voucher. |
|
Outcomes |
Baseline, 1, 2, 3, 4, 5, 6 months CO measured at all time points Baseline and 6 months – blood pressure (BP) and heart rate |
|
Starting date |
Study start date May 2021 |
|
Contact information |
Nicholas I. Goldenson, Juul Labs, Inc., 1000 F Street NW, Suite 800, Washington, DC 20004, United States. Email: Nicholas.Goldenson@juul.com Funding: This study was funded by Juul Labs, Inc. |
|
Notes |
New to 2024 update This study was published then withdrawn. We will monitor to see when this is re-published. Authors stated: “109 participants, who should be in NRT group, were wrongly placed in the EC group, while another 109 participants, who should be in EC group, were wrongly placed in the NRT group." |
|
Study name |
Protocol for randomized, two arm parallel, clinical trial for effectiveness of THR products in Low and Middle Income Counties |
|
Methods |
RCT Recruitment: outpatient clinics and advertisements will be used for the recruitment of participants and directed to contact the trial site by phone, email, or through the study website. Randomisation: A web-based application will be used to issue a computer-generated sequence for randomization by the principal investigator. Setting: Pakistan |
|
Participants |
Target N = 258 Inclusion: Adults who smoke tobacco cigarettes among the general population in Low and Middle Income Countriss and have the motivation to quit. Exclusion: pregnant/ breastfeeding; taking any other NRT and/or enrolled in any other smoking cessation program; any contraindications to products such as cardiovascular history; and/or suffering from a major illness with a prognosis of less than 1 year. |
|
Interventions |
(1) E-cigarettes (18mg/ml) with individual counseling (2) Nicotine patches (21mg) with individual counseling. Both groups: On allocated quit day, the participants will stop smoking and use study product daily for the next twelve weeks. |
|
Outcomes |
Baseline, weeks 1, 2, 4, 8, 12, 18, 24, and 52. 12 week treatment. Abstinence from CC; Use of CC; AEs; Withdrawal; Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. |
|
Starting date |
Not stated |
|
Contact information |
Madeeha Malik, ceo@cyntaxhealthprojects.com |
|
Notes |
Added in 2025. Industry funded (Foundation for a Smoke Free World) |
|
Study name |
Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomized controlled trial to evaluate the effect of adding a personalized smoking cessation intervention to a lung cancer screening programme |
|
Methods |
RCT Setting: Yorkshire, UK |
|
Participants |
Actual recruitment: 1001 people who smoke tobacco cigarettes (target 1040) Participants are aged 55 to 80, registered with a general practitioner (GP) in the Leeds Clinical Commissioning Group area and registered as a current or ex-smoker in primary care databases Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
Arm 1: enhanced, personalized smoking cessation (SC) support package, including CT scan images. SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette Arm 2: continued standard best practice |
|
Outcomes |
Follow-up contact will be requested at 4 weeks, 3 months, and 12 months, with a 2-week window to accommodate participant availability. The primary objective is to measure 7-day point prevalent carbon monoxide (CO)-validated SC after 3 months. Secondary outcomes include CO-validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. |
|
Starting date |
January 2019 and December 2020 with follow-up data collection ending December 2021. Study completion March 2022. |
|
Contact information |
Professor Rachael L Murray; rachael.murray@nottingham. ac.uk |
|
Study name |
Spain-UK-Czech E-cigarette Study (SUKCES) |
|
Methods |
Randomized controlled trial, open-label pilot study Setting: smoking cessation clinics in London, Madrid and Prague Recruitment: via smoking cessation clinics |
|
Participants |
220 people who smoke, seeking help to quit Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
|
|
Outcomes |
|
|
Starting date |
December 2013 |
|
Contact information |
Peter Hajek, p.hajek@qmul.ac.uk |
|
Study name |
Head-to-head comparison of personal vaporizers versus cig-a-like: prospective 6-month randomized control design study (VAPECIG 2) |
|
Methods |
Randomized, parallel-assignment, open-label trial Setting: Italy, community |
|
Participants |
Estimated enrolment: 200 Inclusion criteria:
Exclude if:
|
|
Interventions |
Comparison between 2 types of EC; 'personal vaporizers' and 'cig-a-like' |
|
Outcomes |
24 weeks:
|
|
Starting date |
October 2014. Actual completion December 2015. Authors unable to provide date when study will be available. |
|
Contact information |
Riccardo Polosa |
|
Study name |
Harm reduction for tobacco smoking with support of tobacco-replacing electronic nicotine delivery systems (HaRTS-TRENDS) |
|
Methods |
Parallel, randomized controlled trial Setting: USA Recruitment: from prominent Housing First programmes serving chronically homeless people who are often affected by multiple psychiatric, medical and substance-use disorders. The proposed sample will be recruited from a highly vulnerable and marginalized population in a tight-knit urban community. |
|
Participants |
Estimated enrolment: 94 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
|
|
Outcomes |
Primary outcomes, measured across the 12-month follow-up:
Secondary outcomes, measured across the 12-month follow-up:
Other outcomes:
|
|
Starting date |
9 May 2019 |
|
Contact information |
Tatiana M Ubay, tatiubay@uw.edu |
|
Study name |
Biomarkers of exposure and effect in standardized research e-cigarette (SREC) users |
|
Methods |
Design: RCT Setting: USA |
|
Participants |
Estimated enrolment: 125 Inclusion criteria:
Exclusion criteria:
For a full list see NCT record. |
|
Interventions |
EC: Standardized Research E-cigarette (SREC) Arm 1: Experimental: Switching from Smoking Cigarettes to E (SREC) The device operates at a single output voltage (3.30 ± 0.05 V) and uses sealed disposable 3 mL cartridges with tobacco-flavoured e-liquid (~350 puffs/cartridge). The concentration of nicotine in e-liquid is 15 mg/mL, and the vehicle composition is 50:50 propylene glycol and glycerin. The device uses a battery that can be recharged via a micro USB port. Arm 2: Experimental: Switching from smoking cigarettes to nicotine mini-lozenge We will use commercially available nicotine mini-lozenges containing 2 or 4 mg nicotine/lozenge (Nicorette, manufactured by GlaxoSmithKline). Dose will be determined per instructions on the package (e.g. if smoking within 30 minutes upon awakening, then 4 mg dose will be prescribed). |
|
Outcomes |
1 year 4 and 8 weeks for formaldehyde-DNA adducts and oxidative DNA adduct 8-oxo-dG in DNA Biomarkers: TNE, NNAL, NNN, PneT, mercapturic acids HMPMA, 2-HPMA, 3-HPMA, formaldehyde-DNA adducts, oxidative DNA adduct 8-oxo-dG in DNA, NNN and nornicotine, HPB-releasing DNA adducts cpd, product use (EC and nicotine lozenges), CC avoidance |
|
Starting date |
Actual start date: 11 May 2022. Estimated study completion date: January 2025 |
|
Contact information |
Hanna Vanderloo, RN, MSN 612.624.4983, hannav@umn.edu |
|
Notes |
New to 2022 update |
|
Study name |
Electronic cigarettes as a harm reduction strategy in individuals with substance use disorder |
|
Methods |
Parallel-group, randomized trial Recruitment/setting: Not specified |
|
Participants |
Actual enrollment: 48. Estimated enrolment: 240 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
E-cigarettes arm: Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms. Nicotine Replacement Therapy arm: Nicotine patches and gum to last them the first week based on their baseline recorded smoking. Participants will be advised to use both a 21 mg nicotine patch and 4 mg nicotine for cravings. |
|
Outcomes |
Baseline, 3 weeks. AEs/SAEs. |
|
Starting date |
Start date: October 2020 Estimated completion date 30 June 2024 |
|
Contact information |
NYU Langone Health, Scott.Sherman@nyulangone.org |
|
Notes |
In SRNT abstract no eligible data. To confirm that the SRNT abstract is linked to this study. |
|
Study name |
Electronic cigarettes as a harm reduction strategy among people living with HIV/AIDS |
|
Methods |
RCT Setting: NYU Langone Health, USA |
|
Participants |
Actual enrollment: 64. Estimated enrolment 120. [SRNT abstract N=43] Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
EC: Pod. NIDA Standardized Research E-cigarettes (SREC) (15 mg/mL nicotine in tobacco flavour) Arm 1: counselling + nicotine replacement therapies NRT A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counselling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counselling tailored to the participant's readiness to quit and arm in the study (NRT). Participants will also receive their NRT to last them to the following visit based on their baseline smoking. Arm 2: Counselling + Standardized Research E-cigarettes (SREC) Participants in the SREC arm to practice using the SREC and RA to give them instructions to return with their SREC and used refill tanks on every visit. A research assistant (RA) trained in motivational interviewing and qualitative methods will support the PI to deliver counselling sessions and conduct interviews. Briefly, during each visit, with help of the RA, participants will provide exhaled CO and saliva cotinine test, and complete surveys in REDCAP using a tablet, allowing programmed logic checks and skip patterns to minimize burden. The RA will also deliver brief motivational counselling tailored to the participant's readiness to quit and arm in the study (SREC). Participants will also receive their SREC to last them to the following visit based on their baseline smoking. |
|
Outcomes |
Week 1, 2, 4, 6, 8, 12 Change in cigarettes per day (cpd). Smoking reduction will be measured by a combination of self-report, text message data and changes in CO and saliva cotinine between baseline and end of treatment. Assessing differences in nicotine withdrawal symptoms Assessing differences in e-cigarette dependency Assessing differences in nicotine use Assessing differences in use of substance use Assessing differences in side effects associated with e-cigarette use |
|
Starting date |
Study start date: 17 June 2021. Estimated study completion date: October 2024. |
|
Contact information |
Omar El Shahawy, MD 1-646-501-2587, omar.elshahawy@nyulangone.org |
|
Notes |
New to 2022 update |
|
Study name |
Impact of non-cigarette tobacco product formulation on reinforcement value and use in current smokers Short title: Salt-based e-cigarette |
|
Methods |
RCT Setting: USA, South Carolina |
|
Participants |
Actual enrollment: 24. (Estimated enrollment: 30) Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
Salt-base nicotine Free-base nicotine |
|
Outcomes |
Most preferred product (time frame: Lab visit 2, occurring approximately 1 week after the initial screening/baseline visit) Participants complete a preference assessment in which they choose between the salt liquid, free-base liquid, or a traditional cigarette in a series of trials. The outcome of this assessment is the product chosen most often by each participant. Cigarettes per day (time frame: Week 2 of study) The average number of cigarettes smoked per day during the 1-week sampling period Biomarkers (i.e. expired CO, cotinine) will corroborate self-reported indices of use. |
|
Starting date |
23 June 2020. Estimated completion: August 2021 |
|
Contact information |
Tracy Smith, smithtra@musc.edu |
|
Study name |
Official title: Cigarette consumption after switchinG to high or low Nicotine strENght E-cigaretteS In Smokers with schizophrenia spectrum disorders: a 12-month randomized, double-blind multicentre trial Brief title: Cigarette consumption after switchinG to high or low nicotine strENght E-cigaretteS In Smokers with schizophrenia (GENESIS) NB: The GENESIS protocol (NCT04452175) now incorporates SCARIS protocol, NCT01979796. Antismoking effects of electronic cigarettes in subjects with schizophrenia and their potential influence on cognitive functioning: design of a randomized trial. Smoking Cessation And Reduction In Schizophrenia (The SCARIS Study). clinicaltrials.gov/show/NCT01979796 |
|
Methods |
RCT Multicentre: Italy, Russia, Ukraine, UK Collaborators:
|
|
Participants |
Estimated enrolment: 260 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
|
|
Outcomes |
Primary outcomes:
Secondary outcomes
|
|
Starting date |
Actual start date 30 October 2021. Estimated study completion: February 2023 (NCT record update posted on 23 May 2022) |
|
Contact information |
Pasquale Caponnetto, p.caponnetto@unict.it |
|
Study name |
Effects of menthol in e-cigarettes on smoking behaviors |
|
Methods |
Randomized cross-over Setting: Connecticut Mental Health Center, USA |
|
Participants |
Actual enrollment: 10. Estimated enrolment 85 Inclusion criteria: ≥ 21 years, use combustible cigarettes Exclusion criteria: none |
|
Interventions |
EC: type not stated Arm 1: menthol flavour. Participants will receive 5% nicotine in an EC. Participants will receive 2 nicotine concentrations via EC. Each exposure will be 10 3-sec puffs and ad libitum use. Arm 2: tobacco flavour. Participants will receive 5% nicotine in an EC. Participants will receive 2 nicotine concentrations via EC. Each exposure will be 10 3-sec puffs and ad libitum use. |
|
Outcomes |
Baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure (plasma nicotine levels), 2 weeks (CO), 3 weeks, 5 weeks (BP and heart rate) Primary outcomes: cigarette craving; plasma nicotine levels; carbon monoxide Secondary outcomes: EC craving; irritation/harshness; liking of EC; coolness; nicotine withdrawal; stimulation; EC use; cigarette use. Other outcomes measured: heart rate, blood pressure, pulse oximetry |
|
Starting date |
Study start date: 1 November 2020. Completion date: 25 July 20253 |
|
Contact information |
Asti Jackson, PhD 4752414904, asti.jackson@yale.edu |
|
Notes |
New to 2022 update |
|
Study name |
International randomized controlled trial evaluating changes in oral health in smokers after switching to combustion-free nicotine delivery systems (SMILE) |
|
Methods |
RCT Setting: multicentre: Italy, Moldova, Poland, UK, and Indonesia |
|
Participants |
Estimated enrolment 606 participants Inclusion criteria:
For Arms A and B, participants have to be:
For Arm C, participants have to be:
Exclusion criteria:
|
|
Interventions |
Standard arm (Arm A): own tobacco cigarette brand Intervention arm (Arm B): combustion-free nicotine delivery system (C-F NDS) Control arm (Arm C): no smoking or use of any nicotine/tobacco products |
|
Outcomes |
Oral health parameters and teeth appearance, comparing short- and long-term impact on periodontal health between smokers continuing with conventional cigarette smoking, those switching to combustion-free nicotine delivery systems (C-F NDS), and never-smokers over 18 months |
|
Starting date |
Not yet recruiting (last updated February 2021) Estimated study start date: Feb 2021. Estimated primary completion date: Feb 2023. Estimated completion April 2023. |
|
Contact information |
Principal investigator: Antonio Pacino, DDS, Addendo srl, Catania, Italy info@addendo.net |
|
Study name |
Characterization of product use in smokers switching from cigarettes to a RELX electronic nicotine delivery system Setting: USA |
|
Methods |
Design: RCT, multicentre, open-label, parallel-cohort study |
|
Participants |
Estimated 200 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
RELX ENDS tobacco flavour ad libitum use of the RELX ENDS tobacco flavour product RELX ENDS menthol flavour ad libitum use of the RELX ENDS menthol product Ad libitum use of the RELX ENDS tobacco and menthol flavour products |
|
Outcomes |
Primary outcomes: Weekly RELX ENDS product use; time frame: 56 days. Self-reported number of RELX ENDS pods started each week Daily number of cigarettes smoked; time frame: 56 days. Self-reported number of cigarettes smoked daily by study week Number of puffs from the RELX ENDS each day; time frame: 56 days. Self-reported number of puffs from the RELX ENDS daily by study week (0, < 100, ≥ 100 per day) Secondary outcomes: Biomarkers of exposure measured in blood; time frame: baseline, day 28, and day 56; change in carbon monoxide concentration in the blood Biomarkers of tobacco exposure measured in urine; time frame: baseline, day 28, and day 56; change in creatinine-adjusted NNAL, NNN, 3-HPMA, CEMA, HMPMA, S-PMA, HEMA, 1-OHP, o-toluidine, nicotine equivalents, and propylene glycol excreted in urine Subjective effects as measured by the Penn State (Electronic) Cigarette Dependence Index (PS(E)CDI); time frame: baseline, day 14, day 28, day 42, and day 56. Change in product dependence as measured by the PSCDI/PS(E)CDI total score. Total scores may range for 0 to 20, with higher levels of dependence associated with higher scores. Subjective effects as measured by the Cough Questionnaire; time frame: baseline, day 14, day 28, day 42, and day 56. Change in self-reported cough symptoms as measured by responses to the Cough Questionnaire Subjective effects as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief); time frame: baseline, day 14, day 28, day 42, and day 56. Change in smoking urge as measured by the QSU-Brief factor 1 and factor 2 scores. Questionnaire responses are measured on a Likert scale range of 1 (not at all) to 7 (extremely). Subjective effects as measured by the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R); time frame: baseline, day 14, day 28, day 42, and day 56. Change in withdrawal symptoms as measured by the MTWS-R total score, which includes the DSM-5 and craving items from the Minnesota Tobacco Withdrawal Scale. Questionnaire responses are measured on a Likert scale range of 0 (none) to 4 (severe)). Subjective effects as measured by the Modified Product Evaluation Scale (mPES); time frame: baseline, day 14, day 28, day 42, and day 56. Change in product assessments as measured by mPES satisfaction, psychological reward, aversion, and relief subscale scores. Questionnaire responses are measured on a Likert scale range of 1 (not at all) to 7 (extremely). Subjective effects as measured by the Future Intent to Use Questionnaire; time frame: baseline, day 14, day 28, day 42, and day 56. Change in future intent to use cigarettes and ENDS products as measured by responses to the Future Intent to Use Questionnaire Questionnaire responses are measured on a Likert scale range of 1 (extremely unlikely) to 7 (extremely likely) Subjective Effects as measured by the Health Effects Perceptions Questionnaire; time frame: baseline and day 56. Harmful and addictiveness perceptions as measured by responses to the Health Effects Perceptions Questionnaire Puff topography - number of puffs; time frame: baseline, day 28, and day 56. Change in the number of puffs during a 1-hour puff topography session Puff topography - puff duration; time frame: baseline, day 28, and day 56. Change in puff duration during a 1-hour puff topography session Puff topography - puff volume; time frame: baseline, day 28, and day 56. Change in puff volume during a 1-hour puff topography session Puff topography - peak puff flow rate; time frame: baseline, day 28, and day 56; change in peak puff flow rate during a 1-hour puff topography session Puff topography - average flow rate; time frame: baseline, day 28, and day 56. Change in average flow rate during a 1-hour puff topography session Puff topography - inter-puff interval; time frame: baseline, day 28, and day 56. Change in inter-puff interval during a 1-hour puff topography session RELX ENDS product use; time frame: day 28 and day 56; change in pod weight during a 1-hour topography session Incidence of product-use emergent adverse events (safety and tolerability); time frame: 56 days Incidence of product-use emergent adverse events |
|
Starting date |
Study start date: 15 October 2020. Estimated completion date: April 2021 |
|
Contact information |
Study Director: Donald Graff. Principal Investigator: Mark Adams, MD Cheerain HK Limited. AMR, USA. Pillar Clinical Research, USA. QPS, USA. No contact details provided. |
|
Study name |
E-cigarette nicotine study |
|
Methods |
Design: RCT. Parallel-group assignment Setting: USA Start date: 20 January 2021. Estimated completion date: September 2021 |
|
Participants |
Actual enrollment 77. Estimated: 75 Eligibility criteria include at least 21 years old, use e-cigarettes and tobacco cigarettes regularly, not planning to quit in the near future, and not pregnant, breastfeeding or planning to become pregnant or breastfeed in the next 2 months Additional criteria will be evaluated to assess for eligibility. |
|
Interventions |
Experimental: Switch to low-nicotine e-cigarettes: switch to e-cigarettes containing 60% of baseline e-cigarette nicotine content. Device: Juul e-cigarette. Participants will switch to Juul pods containing less nicotine. Experimental: Reduce number of e-cigarette pods: reduce e-cigarette use to 60% of baseline number of pods per week No Intervention: Use e-cigarettes as usual: continue using nicotine e-cigarettes as usual |
|
Outcomes |
Baseline, 4 week reduction period, 8 weeks. All participants will complete a web-based follow-up survey and provide a breath CO sample 4 weeks after study completion (i.e., 8 weeks after randomization) to assess tobacco use, ENDS use, quit attempts, and behavioral economic measures. Primary outcome measure: Feasibility; time frame: Baseline and the 4-week reduction period. The investigators will assess compliance with study e-cigarettes and compare the percentage of non-study e-cigarette use between conditions to determine which behaviour-changing strategy is more feasible. Combustible cigarette smoking; time frame: Baseline and the 4-week reduction period. The investigators will compare change in number of cigarettes per day between conditions. Cigarette dependence; time frame: Baseline and the 4-week reduction period. The investigators will compare change in cigarette dependence between conditions using the PATH dependence measure. E-cigarette dependence: time frame: Baseline and the 4-week reduction period. The investigators will compare change in e-cigarette dependence between conditions using the PATH dependence measure. Secondary outcome measure: Cigarette demand; time frame: Baseline and the 4-week reduction period. The investigators will compare change in cigarette demand using the Brief Assessment of Cigarette Demand task. E-cigarette demand; time frame: Baseline and the 4-week reduction period. The investigators will compare change in e-cigarette demand using a version of the Brief Assessment of Cigarette Demand task adapted for e-cigarettes. |
|
Starting date |
20 January 2021. Study completion date: June 2022. |
|
Contact information |
Elias M Klemperer, PhD802-656-1641, elias.klemperer@med.uvm.edu |
|
Study name |
Concentration Impact Nicotine Salt (CINS) |
|
Methods |
Design: RCT |
|
Participants |
Estimated enrolment: 312 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
Active comparator: Active arm, low concentration (18 mg/mL) nicotine salt e-liquids. Procedure: Smoking cessation counselling: smoking cessation counselling at baseline, week 1, week 2 and week 4 Active comparator: Active arm, high concentration (59 mg/mL) nicotine salt e-liquids. Procedure: Smoking cessation counselling: smoking cessation counselling at baseline, week 1, week 2 and week 4 Control group: Receive only smoking cessation counselling. Procedure: Smoking cessation counselling: smoking cessation counselling at baseline, week 1, week 2 and week 4 |
|
Outcomes |
Primary outcome: 7-day point prevalence tobacco abstinence (in terms of non-inferiority); time frame: 1 month. Defined as no smoking, i.e. "not a puff", self-reported and confirmed by exhaled carbon monoxide (< 10 ppm) and urinary anabasine levels (< 3 ng/mL) when using low vs. high nicotine salt concentration e-liquids Volume of e-liquid used (in terms of superiority); time frame: 1 month; volume of e-liquid used when using low vs high nicotine salt concentration e-liquids Secondary outcome: 7-day point prevalence tobacco abstinence (in terms of non-inferiority); time frame: 1 month. Defined as no smoking, i.e. "not a puff", self-reported and confirmed by exhaled carbon monoxide (< 10 ppm) and urinary anabasine levels (< 3 ng/mL) when using low vs. high nicotine salt concentration e-liquids Volume of e-liquid used (in terms of superiority); time frame: 1 month; volume of e-liquid used when using low vs high nicotine salt concentration e-liquids Liking/rating of trial product (active arms); time frame: 1 and 3 months. Questions regarding helpfulness in refraining from smoking, how satisfying and how good the e-cigarette tastes compared to the tobacco cigarettes, if they would recommend the assigned trial product to another smoker, and any potential practical problems they might have with the handling Respiratory symptoms; time frame: up to 12 months; checklist with specific questions regarding shortness of breath, wheezing, cough or phlegm Adverse events; time frame: up to 12 months; checklist with specific questions regarding presence or absence of nausea, sleep disturbance, throat/mouth irritation, or other Total nicotine amount vaped; time frame: 1 and 3 months Total volume of e-liquid consumed; time frame: 1 and 3 months |
|
Starting date |
Start date: Jan 2024. Estimated study completion date: 31 Dec 2024 |
|
Contact information |
Evangelia Liakoni, MD0041316325461, evangelia.liakoni@insel.ch |
|
Study name |
Potential effects of electronic nicotine delivery system flavor regulations on African American menthol smokers (RVA Flavors) |
|
Methods |
RCT |
|
Participants |
Actual enrollment 71. Estimated enrolment: 210 Inclusion criteria: 21+ years; identify as Black/African-American (single or multi-race); used ≥ 5 cigarettes per day for ≥ 1 year (biochemically confirmed); regular cigarette brand menthol or mint flavoured; EC use in the past 30 days; no intent to quit smoking in the next 6 months; previous quit attempt using evidence-based method; mobile phone, willing to receive calls/text Exclusion criteria: unwilling to use EC; report other tobacco use > 10 days in past 30 other than combustible cigarettes; unstable or significant medical condition in the past 12 months; > 15 days of marijuana or other illegal drug use in the past 30 days; pregnancy/breastfeeding |
|
Interventions |
EC: type not stated Arm 1: Menthol + tobacco. Both menthol and tobacco-flavoured liquids for EC are available to choose from. Arm 2: Tobacco - only tobacco-flavoured liquid is available for EC. Arm 3: Unflavoured - only unflavoured liquid is available for EC. Participants are instructed to smoke their usual brand of menthol cigarettes normally for 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 EC flavour conditions; all contain 5% nicotine (menthol + tobacco, tobacco, unflavoured) with equal probability and provided with a supply of their condition-specific EC and asked to use it in place of their usual menthol cigarettes for the next 6 weeks. |
|
Outcomes |
Week 1, week 6 Change in: average daily cigarette use; carbon monoxide exposure; urinary NNAL; urinary propylene glycol exposure; average daily ENDS use Willingness to substitute from cigarettes to EC (ENDS); measure of substitution for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced. Willingness to pay for ENDS (week 6); willingness to pay for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced. |
|
Starting date |
Study start date: 14 April 2022. Estimated primary completion date: June 2025 |
|
Contact information |
Andrew J. Barnes, PhD 804-827-4361, abarnes3@vcu.edu Caroline O. Cobb, PhD, cobbco@vcu.edu |
|
Notes |
New to 2022 update |
|
Study name |
Risk and benefits of electronic cigarettes to older smokers at high risk for lung cancer |
|
Methods |
RCT Setting: M. D. Anderson Cancer Center, Texas, USA |
|
Participants |
Estimated enrolment: 330 Inclusion criteria: meeting National Comprehensive Cancer Network (NCCN) guideline for lung cancer screening; daily or non-daily smoker; interested in trying ECs to change CC smoking behaviour; willing and able to complete two spirometry sessions Exclusion criteria: used ECs on more than 2 days in the past 30 days; meet criteria for current major depressive disorder (MDD) or suicidality; report more than once weekly of tobacco products other than CCs during the past 30 days; ever diagnosis of lung cancer, have uncontrolled or unstable medical condition; spirometry forced expiratory volume in 1 second (FEV1) percentage reading < 50; pregnancy/breastfeeding |
|
Interventions |
EC: type not specified GROUP A: Participants smoke their usual brand of cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks. GROUP B: Participants vape EC for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 mins and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks. |
|
Outcomes |
1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks Primary outcome measure: cigarettes per day, diary data of combustible cigarette use over last 24 hours Secondary outcome measures: high-sensitivity C-reactive protein (hs-CRP); white blood cells (WBC); 8-epi prostaglandin F2 alpha (8-epi-PGF2a). All from blood draws at weeks 0, 6, 12, and 26 |
|
Starting date |
Start date: 7 March 2022. Estimated completion date: 30 April 2025 |
|
Contact information |
Jason Robinson, PHD 713-792-0919, jdrobinson@mdanderson.org |
|
Notes |
New to 2022 update |
|
Study name |
Understanding the impact of cartridge-based electronic cigarettes and generated aerosols on cardiopulmonary health |
|
Methods |
Two groups recruited: EC users and demographically matched non-EC users. NCT record: 'Randomised' 'parallel assignment'. Virginia Commonwealth University, USA |
|
Participants |
Actual enrolment: 64 Inclusion criteria for EC group: ≥ 21 yrs; used EC (≥ 3 times/week for ≥ 3 months) Inclusion criteria for the group not using EC (Non-e-cigarette group: ≥ 21 yrs Exclusion criteria: use of cigarettes for 15 days or more in the past 60 days; use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days; use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days; allergy to propylene glycol or vegetable glycerin; evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases; disorder or use of medication that affects cardiopulmonary health; pregnancy/breastfeeding |
|
Interventions |
EC: commercially available cartridge-based EC device Arm 1: E-cigarette liquid type 1 (tobacco flavour) A commercially available cartridge-based device with tobacco-flavoured liquid. Participants will be instructed to use at least one study product daily in place of their own EC during the intervention period. Arm 2: E-cigarettes liquid type 2 (tobacco flavour) A commercially available cartridge-based device with tobacco-flavoured liquid. Participants will be instructed to use at least one study product daily in place of their own EC during the intervention period. Arm 3: No e-cigarettes. No e-cigarette use |
|
Outcomes |
Baseline, 2 weeks Change in peak oxygen consumption (VO2 peak) Change in expiratory volume Change in skeletal muscle O2 utilization Change in maximal microvascular dilation |
|
Starting date |
Study start date: 10 January 2022. Study completion 30 July 2024. |
|
Contact information |
Paula Rodriguez Miguelez, PhD804-396-4498, prodriguezmig@vcu.edu |
|
Notes |
New to 2022 update |
|
Study name |
A randomized controlled trial to determine the effects of combination zonisamide and bupropion on switching to an electronic cigarette |
|
Methods |
RCT Rose Research Center, USA |
|
Participants |
Estimated enrolment: 180 Inclusion criteria: 21 to 65 yrs; ≥ 10 commercially available cigarettes per day, for the last 12 months (CO reading ≥ 10 ppm); interested in switching to an EC; smartphone with text message and data capabilities Exclusion criteria: unhealthy or cannot participate in the study for any reason; PHQ-9 score greater than 9, or a score greater than 0 on item #9; plans to use an FDA-approved smoking cessation product; high blood pressure, coronary heart disease, structural cardiac disease; BMI ≤ 15.0 kg/m2 or > 40.0 kg/m2; depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study, taking antidepressants, psychoactive medications or medications that prolong QTc For full list see NCT record |
|
Interventions |
EC: JUUL Zonisamide Bupropion Arm 1: Combination zonisamide and bupropion with EC After the first week of EC use (JUUL), participants will be given bupropion (150 mg each morning for days 1 to 3, then 300 mg daily) with zonisamide (100 mg daily). The combination of zonisamide and bupropion use will continue for 7 weeks of treatment, and EC use will continue until the end of the study (an additional 4 weeks). EC for ad libitum use for 2 weeks prior to complete switch day and for an additional 10 weeks Arm 2: Bupropion with EC After the first week of EC use (JUUL), participants will be given bupropion (150 mg each morning for days 1 to 3, then 300 mg daily) with placebo zonisamide. The combination of placebo and bupropion use will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks). EC for ad libitum use for 2 weeks prior to complete switch day and for an additional 10 weeks Arm 3: Placebo with EC After the first week of EC use (JUUL), participants will be given placebo bupropion with placebo zonisamide. The combination of these placebos will continue for 7 weeks of treatment, and EC use will continue until the end of the study (an additional 4 weeks). EC for ad libitum use for 2 weeks prior to complete switch day and for an additional 10 weeks |
|
Outcomes |
Baseline, week 8, week 12, 6 months Complete switching from combustible cigarettes to JUUL EC as measured by: exhaled carbon monoxide (CO); change in total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL); change in self-report of daily cigarette and EC use Seven-day point abstinence at 6 months post-switch, assessed by self-report and confirmed by exhaled CO < 5 ppm. Change in smoking withdrawal symptoms. Change in rewarding and aversive effects of smoking and EC use AEs; SAEs |
|
Starting date |
Start date: 14 December 2021. Estimated completion date: 30 June 2024 |
|
Contact information |
Derek Mercedes 704-350-2999, derek.mercedes@roseresearchcenter.com |
|
Notes |
New to 2022 update |
|
Study name |
Methadone-maintained smokers switching to e-cigarettes (SHINE) |
|
Methods |
RCT Butler Hospital, Providence, Rhode Island, United States, 02906 |
|
Participants |
Estimated enrolment: 240 Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
EC: type not stated Arm 1: Electronic cigarettes. Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period. Electronic cigarettes are provided to replace tobacco cigarettes. Arm 2: Nicotine lozenges. Participants in this arm are randomized to receive nicotine lozenges for the 6-week study period. Nicotine lozenges are provided to replace tobacco cigarettes. |
|
Outcomes |
Baseline, 6 weeks Nicotine exposure (urine) Lung functioning: FVC (changes in Forced Vital Capacity, spirometry); FEV1 (changes in Forced Expiratory Volume (FEV - during the first second), spirometry) Smoking behaviour and experiences (self-report) For complete switchers: nicotine exposure; lung functioning (FVC, FEV1, FEV1/FVC); smoking behaviour and experiences |
|
Starting date |
Study start date: 31 March 2022. Estimated study completion date: 30 June 2024. |
|
Contact information |
Michael Stein, MD 401-455-6200, michael_stein@brown.edu Ana Abrantes, PhD 401-455-6200, ana_abrantes@brown.edu |
|
Notes |
New to 2022 update |
|
Study name |
Aggressive smoking cessation therapy post-acute coronary syndrome (ASAP) trial |
|
Methods |
RCT Setting: hospital Jewish General Hospital, USA |
|
Participants |
Estimated enrolment: 798 Inclusion criteria: Currently hospitalized (or at time of discharge) for ACS. Defined as follows: MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs). For definition, see NCT record. CC user; motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5); ≥ 18 years Exclusion criteria: Use of any of the following in the 30 days prior to ACS admission: i. Pharmacotherapy (e.g. NRTs, bupropion, or varenicline) for smoking cessation; ii. Nicotine or non-nicotine e-cigarettes; iii. Psychotropic medications (e.g. mood stabilizers, antipsychotics, prescribed opiates and sedatives); iv. Other anti-craving medication (e.g. naltrexone, acamprosate) with the potential to alter substance-seeking behaviours Pregnancy/breastfeeding For a full list, see NCT record. |
|
Interventions |
EC: participant's choice Arm 1: Combination therapy arm (varenicline and nicotine EC plus counselling) Patients in the combination therapy arm will be supplied funds and instructions for the purchase of EC and cartridges/pods upon hospital discharge and at the week 4 and 12 clinic visits. As with standard NRTs such as the gum, inhaler, and lozenge, we expect smokers will self-regulate administration according to their withdrawal symptoms. Use will be monitored via self-report for telephone follow-ups. At clinic visits, patients will be asked to bring their EC, used and unused cartridges/pods, and purchasing receipts. Patients will be advised regarding the signs and symptoms of nicotine toxicity and of an allergic reaction. Arm 2: Varenicline plus counselling All patients will begin varenicline in-hospital upon randomization. For the first 3 days, patients will take a 0.5 mg tablet once a day. They will then take a 0.5 mg tablet twice a day for the following 4 days, and one 1 mg tablet twice a day from day 8 onward for the remainder of the 12-week treatment. Use will be monitored via self-report for telephone follow-ups and return of all unused tablets at the end of the treatment period. Should a patient experience severe side effects (such as headache, nausea, vomiting, dizziness, dyspepsia, fatigue, insomnia, abnormal dreams, constipation, or flatulence) on day 8 onward, the varenicline dose should be reduced from 1 mg twice daily to 0.5 mg twice daily prior to study medication discontinuation. |
|
Outcomes |
1, 2, 8, 18, 24 weeks Week 4, week 12, and week 52 Number of participants with: 7-day point prevalence smoking abstinence (biochemically-validated); continuous smoking abstinence; prolonged smoking abstinence; change in daily cigarette consumption; ≥ 50% reduction in daily cigarette consumption; point prevalent abstinence or ≥ 50% reduction in daily cigarette consumption at 24 weeks Frequency of adverse events (AEs) or SAEs Spirometry measurements (subset) at all other clinic visits (FVC, FEV1, and FEV1/FVC) O2 cost diagram and COPD Assessment Test (subset) at all other clinic visits Number of patients averaging ≥ 1 pill of varenicline/day |
|
Starting date |
Estimated start date: 1 June 2022. Estimated completion date: 7 March 2027 |
|
Contact information |
Carole Bohbot 514-340-8222 ext 22790 ASAP.Trial@ladydavis.ca, carole.bohbot@ladydavis.ca |
|
Notes |
New to 2022 update |
|
Study name |
Impact of e-cigarette training on puff patterns, cigarette smoking, and health outcomes among smokers with COPD; COPD e-cigarette topography training |
|
Methods |
Design: RCT. An open-label, randomized clinical trial of e-cigarette training and training dose amongst smokers with COPD Smokers with COPD (n = 45) stratified by e-cigarette use history (naïve vs current use) will be randomized (1:1:1) to receive 1) brief advice to switch to e-cigarettes, 2) single-session e-cigarette training, or 3) enhanced e-cigarette training. Setting: University of Kansas Medical Center (KUMC) campus in Kansas City, Kansas (KS), USA Study start date March 2022. Study end June 2023. |
|
Participants |
N = 45 Smokers with COPD (n = 45) stratified by e-cigarette use history (naïve vs current use) will be randomized (1:1:1) to receive 1) brief advice to switch to e-cigarettes, 2) single-session e-cigarette training, or 3) enhanced e-cigarette training. Inclusion criteria: smokers or dual users diagnosed with COPD; ≥ 21 years old; speak and understand English; smoke on > 25 of the last 30 days for the past 3 months; willing to switch from cigarettes to the study e-cigarette for the duration of the study; have tried but failed to quit smoking in the last year; unwilling to make a pharmacotherapy-assisted quit attempt in the next 30 days Exclusion criteria: smokers or dual users; use of tobacco products other than cigarettes, including e-cigarettes in the past 30 days; current use of cessation medications; pregnant, planning to become pregnant, or breastfeeding; recent history of cardiovascular or pulmonary events in the past 3 months; household member current or previously enrolled in the study |
|
Interventions |
EC. The study product is an e-cigarette device and is available for sale in the US.
|
|
Outcomes |
12 weeks Changes in puff duration in seconds from pre- to post-e-cigarette training (time frame: 12 weeks) Complete switch to e-cigarette (time frame: 12 weeks) Change in spirometry FVC, FEV1, FEV1/FVC ratio, systolic blood pressure, change in diastolic blood pressure, change in COPD Assessment Test (CAT) score, respiratory symptoms score, change in 6-minute walk test distance |
|
Starting date |
Study start date March 2022 |
|
Contact information |
Eleanor Leavens, Assistant Professor, University of Kansas Medical Center |
|
Notes |
New to 2023 update |
|
Study name |
The impact of menthol flavoring on switching in adult menthol smokers |
|
Methods |
Design: Randomized parallel assignment Setting. USA; University of Kansas Medical Center |
|
Participants |
Estimated enrolment: 800 participants Inclusion criteria: ≥ 21 years of age; smoke ≥ 5 cigarettes per day (CPD); smoke menthol cigarettes for ≥ 6 months; verified smoker (CO > 5ppm); functioning telephone; interested in switching to e-cigarettes Exclusion criteria: interested in quitting smoking; use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes); e-cigarette use on ≥ 4 of the past 30 days; uncontrolled hypertension: BP ≥ 180 (systolic) or ≥ 105 (diastolic); use of smoking cessation pharmacotherapy in the month prior to enrolment; pregnant, contemplating getting pregnant, or breastfeeding Motivated to quit: no |
|
Interventions |
EC: 4th generation nicotine salt-based pod-system e-cigarette in menthol versus tobacco-flavoured e-liquid Arm 1. Menthol flavour electronic cigarette. 400 adult cigarette smokers will receive 12 weeks of menthol-flavoured electronic cigarettes. Arm 2. Tobacco flavour electronic cigarette. 400 adult cigarette smokers will receive 12 weeks of tobacco-flavoured electronic cigarettes. Participants will receive 12 weeks of menthol OR tobacco-flavoured electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes. |
|
Outcomes |
Baseline, 12 weeks. Follow-up will continue to 26 weeks. Outcomes at 12 weeks 1. Number of participants who switch from cigarettes to electronic cigarettes at week 12 Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO < 6 ppm and predominant switching; defined as use of the e-cigarette with > 50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes in facilitating switching at week 12. 2. Assessment of respiratory symptoms using spirometry Spirometry summarizing forced expiratory flow (FEF) 25-75% and the American Thoracic Society Questionnaire will assess acute respiratory symptoms experienced by cigarette and electronic cigarette smokers. This will help assess the tobacco harm reduction of electronic cigarettes. 3. Amount of e-liquid consumed |
|
Starting date |
8 November 2022. Estimated primary completion date 30 June 2025 |
|
Contact information |
Tricia Snow, 816-398-8960 psnow@kumc.edu PI Nicole Nollen, PhD, University of Kanas Medical Center |
|
Notes |
New to 2023 update |
|
Study name |
Pulmonary and cardiac effects of e-cigarette use in pulmonary patients who smoke cigarettes |
|
Methods |
Design: Randomized, cross-over, open-label Setting: Greater Burlington, VT, USA |
|
Participants |
Actual enrollment: 21. (Estimated enrolment: 25) Inclusion criteria: men and women 40 years of age or older; current, every-day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8 ppm or greater; established pulmonary disease (chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e. LABA, LAMA, ± ICS, or combination); no intention to quit smoking within the next month Exclusion criteria: patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months); inability to conduct in-home measurements Motivated to quit: no |
|
Interventions |
EC: JUUL/Vuse Alto and pods Experimental: e-cigarette. Participants in this arm will smoke electronic cigarettes for 2 weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavour at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavour at 1.8%, 2.4%, or 5% nicotine concentration) will be provided. In the EC arm, availability of e-cigarettes and altering the availability of financial incentives for abstaining from combustible cigarettes will be investigated. No intervention: combustible cigarette. Participants in this arm will smoke their usual brand of combustible cigarettes for 2 weeks. |
|
Outcomes |
Baseline, 2 weeks, 4 weeks Baseline and change from baseline: FEV1/FVC; lung reactance; oxygen saturation (SpO2); exhaled nitric oxide (FeNO); COPD; blood pressure; heart rate; tobacco use; Fagerstrom Test of Nicotine Dependence (FTND); Wisconsin Inventory of Smoking Dependence Motives-Brief (WISDM-Brief); Minnesota Tobacco Withdrawal Scale (MNWS); Questionnaire on Smoking Urges-Brief (QSU-Brief); health changes |
|
Starting date |
Starting date 28 April 2022; completion date December 2023 |
|
Contact information |
Brian R Katz, PhD, 8025511798, Brian.Katz@uvm.edu Shannon O'connor, 8025511798, shannon.oconnor@uvm.edu |
|
Notes |
New to 2023 update |
|
Study name |
4th generation e-cigarettes in African American smokers: reducing harm and quitting combustible cigarettes in dual users Brief title: Switching to e-cigarettes in African-American smokers |
|
Methods |
Design: Randomized, parallel-assessment interventional study Setting: Missouri, USA. Swope Health Central, Kansas City, Missouri, United States, 64130. University of Kansas Medical Center, Kansas City, Missouri, United States, 64130 |
|
Participants |
Estimated N = 500 Inclusion criteria: African-American; ≥ 21 years of age; smoke > 5 cigarettes per day; smoked cigarettes for > 6 months; verified smoker (CO > 5 ppm); interested in switching to EC Exclusion criteria: interested in quitting smoking; use of smoking cessation pharmacotherapy in the month prior to enrolment; use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes); EC use on > 4 of the past 30 days; uncontrolled hypertension: BP > 180 (systolic) or > 105 (diastolic); heart-related event in the past 30 days; medical contraindications to VAR: unstable cardiac condition (e.g. unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation; pregnant, contemplating getting pregnant, or breastfeeding Motivated to quit: no |
|
Interventions |
EC: Nicotine salt pod-based e-cigarette in 5% nicotine Arm 1: Experimental: varenicline and electronic cigarette At the end of the 6-week open-label phase, dual users of cigarettes and e-cigarettes will receive 1 mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette. Drug: Varenicline Tartrate, 0.5 mg once daily for days 1 to 3, 0.5 mg twice daily for days 4 to 7 and 1.0 mg twice daily from day 8 through week 12. Electronic cigarette: nicotine salt pod-based e-cigarette in 5% nicotine Arm 2: Placebo comparator: placebo and electronic cigarette At the end of the 6-week open-label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette. Drug: placebo 1 pill (white) once daily for days 1 to 3, one pill (white) twice daily for days 4 to 7 and 1 pill (blue) twice daily from day 8 through week 12. Electronic cigarette: nicotine salt pod-based e-cigarette in 5% nicotine Arm 3: Open-label electronic cigarette All participants will receive an initial 6-week supply of the study electronic cigarette. Nicotine salt pod-based e-cigarette in 5% nicotine |
|
Outcomes |
Baseline, 6 weeks, 12 weeks. FU to 52 weeks Reduction in toxicant exposure as measured by NNAL excretion from baseline to week 6 CO verified 7-day point prevalence abstinence from cigarettes at week 12 post-randomization |
|
Starting date |
Estimated study start date 30 June 2023. Estimated completion date 30 November 2024. |
|
Contact information |
Tricia Snow, MPH, 816-398-8960, psnow@kumc.edu |
|
Notes |
New to 2023 update |
|
Study name |
Effectiveness and impact of counseling enhanced using electronic cigarettes for harm reduction in people with serious mental illness Brief title: E-cigarettes for harm reduction among smokers with serious mental illness |
|
Methods |
Design: randomized, parallel-assignment. RCT Setting: NYU Langone Health, USA |
|
Participants |
Estimated enrolment: 60 Inclusion criteria: currently smokes 5 or more CPD; age of at least 21 years; has SMI diagnosis (such as schizophrenia, schizoaffective disorders, bipolar disorder, depressive disorders, trauma and stressor-related disorders etc.) as determined using the MINI tool; interested in reducing CC smoking but not necessarily trying to quit Exclusion criteria: pregnant /breastfeeding; used tobacco other than CC in the past 2 weeks (e.g. EC, cigarillo); currently engaged in an attempt to quit CC; change in dose of their psychotropic medication(s) in the last 30 days; meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders; past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days Population: people with serious mental illness (SMI) Motivated to quit: interested in reducing but not interested in quitting |
|
Interventions |
EC: NJOY Ace Electronic Cigarette Intervention period: 8 weeks Arm 1. Experimental: e-cigarettes (EC) Interventions: E-cigarette (EC) NJOY Ace; behavioural: harm-reduction counselling; behavioural: Ecological Momentary Intervention (EMI) text messaging Arm 2. Active comparator: nicotine replacement therapy (NRT) Interventions: Other: nicotine replacement therapy (NRT) (patches, lozenges and gum); behavioural: harm-reduction counselling; Behavioural: Ecological Momentary Intervention (EMI) text messaging Description of behavioural intervention for both groups Behavioural: harm-reduction counselling. At baseline, after randomization, participants will receive their first telehealth session (20 to 25 minutes) from a counsellor trained in motivational interviewing, harm reduction, and smoking cessation. Up to 5 additional sessions will be delivered, 15 to 20 minutes each. Behavioural: Ecological Momentary Intervention (EMI) text messaging. EMI can be defined as delivering tailored interventions via electronic messages (i.e. regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period. |
|
Outcomes |
Baseline, wk 4, wk 8, wk 12 Abstinence from CC (wk 4, wk 8, wk 12). Self-report (daily diary about smoking behaviour) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm) Self-reported percent change in CPD (baseline to wk 8, baseline to wk 12) Change in American Thoracic Questionnaire Score from baseline to wk 12. 8-item questionnaire assessing general thoracic pain Change in Symptom Check Questionnaire Score from baseline to wk 12. 9-item assessment of chronic obstructive pulmonary disease (COPD) symptoms |
|
Starting date |
Estimated start date: July 2023. Estimated completion date: March 2024. |
|
Contact information |
Omar El-Shahawy, 646-501-3587, Omar.ElShahawy@nyulangone.org Adetayo Fawole, 646-501-3568, Adetayo.fawole@nyulangone.org |
|
Notes |
New to 2023 update |
|
Study name |
Randomized, two arm parallel, clinical trial to compare effectiveness of different tobacco harm reduction products in general adult population in low middle income countries |
|
Methods |
Design: randomized, parallel-assignment, 2-arm trial Setting: low-middle-income countries |
|
Participants |
Estimated enrolment: 258 Inclusion criteria: at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested in stopping smoking Exclusion criteria: pregnant/breastfeeding; using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline); any contraindications to products such as cardiovascular history; major illness with prognosis of less than 1 year Motivated to quit: yes |
|
Interventions |
EC: EC 18 mg/mL designed to resemble tobacco cigarettes, aerosol generator, sensor, battery and storage area for liquid. Disposable or rechargeable Study Arm 1: 18 mg nicotine EC (ad libitum use) for 12 weeks after the nominated quit date Free EC and sufficient nicotine cartridges (18 mg/mL) supply to last till next in-person visit. Participants will be instructed to use the device ad libitum 1 week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the EC exclusively for the next 12 weeks. CC users often take 10 to 15 puffs over the course of 5 to 8 minutes, repeating this pattern with each cigarette. EC users may periodically use it throughout the day, and they may or may not take their puffs like those of traditional CCs. Study Arm 2: 21 mg nicotine patches (one daily) for 12 weeks after the nominated quit date 21 mg nicotine patches supply to last until the next-person visit. Participants will use the nicotine patch daily for 1 week before their quit day to familiarize themselves with its use. On their designated quit day, they will stop smoking and use nicotine patches daily for the next 12 weeks. Usually, a full-strength patch (15 to 22 mg of nicotine) daily for 4 weeks is suggested for use in the majority of smokers, followed by a lower-strength patch (5 to 14 mg of nicotine) for an additional 4 weeks, depending on their body size and smoking habits. The nicotine patches are applied on the skin and nicotine is delivered at a steady rate. After administration, the peak blood levels are achieved within 6 to 10 hours. The levels remain constant, reducing by 25% to 40% with use of patches once daily. The patch is typically administered every 24 hours for no longer than 12 weeks. The dose of the patches is often determined by daily cigarette consumption and level of addiction. The duration of counselling will be at least 30 minutes on site. The duration of counselling through telephone will be at least 10 minutes. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for 8 study visits in total, including 5 treatment sessions and 3 follow-up visits, using both face-to-face interaction at the trial site as well as follow-up on telephone. |
|
Outcomes |
Weeks 1, 2, 4, 8, 12, 18, 24, and 52 7 day PP. Self-report having smoked no cigarettes in the past 7 days Number of cigarettes smoked per day assessed using self-reported diaries AEs (time frame 12 weeks). AEs evaluated using Naranjo Adverse Drug Reaction Probability Scale Physical signs and symptoms of withdrawal using Fagerstrom test for nicotine dependence Perception of the product |
|
Starting date |
Estimated study start date: September 2023. Estimated primary completion date: March 2025 |
|
Contact information |
Ather Mehmood, FCPS +92518314299, athermehmood70@gmail.com |
|
Notes |
New to 2023 update Funded by: Foundation for a Smoke Free World INC |
|
Study name |
Switching individuals in treatment for opioid use disorder who smoke cigarettes to the SREC |
|
Methods |
Design: waiting-list controlled RCT Setting: Massachusetts General Hospital, USA |
|
Participants |
Estimated enrolment: 40 Inclusion criteria: 18 +; report daily cigarette smoking (≥ 10 cigarettes per day in the past week); not ready to quit smoking (not planning to quit in the next 30 days); willing to try EC; in stable buprenorphine (BUP) treatment for opioid use disorder at a Massachusetts General Hospital-affiliated primary care clinic (in treatment for ≥ 3 months without changes in BUP dose in the past 2 wks and planning to remain on current BUP treatment for ≥ 3 months) Exclusion criteria: pregnant/breastfeeding; using non-cigarette nicotine or tobacco products (e.g. EC, cigarillos) recently (> 3 days in past 30 days); report past 30-day use of behavioural or pharmacologic smoking cessation aids; have an unstable psychiatric or medical condition Motivated to quit: no EC use at baseline: no |
|
Interventions |
EC: NIDA standardized research e-cigarette (SREC) Arm 1. Experimental: Immediate standardized research EC (SREC) provision (iSREC) Those randomized to the iSREC group will be provided a free 8-week supply of standardized research e-cigarettes (SRECs) and asked to try to switch completely to the SREC. Arm 2. Active Comparator: Delayed SREC provision waiting-list control (WLC) Those in the WLC condition will receive SREC provision after an 8-week delay. |
|
Outcomes |
Baseline, 2 wks, 8 wks SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waiting-list control [WLC]). They will be followed for an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC). 1) tobacco use behaviour (CPD, SREC use), 2) biomarkers (e.g. carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g. respiratory symptoms, substance use) Change in cigarettes smoked per day (CPD) between randomized groups. Change in mean number of CPD in the past 7 days from baseline 2 to week 8 comparing between randomized groups (iSREC group vs WLC) EC use during EC provision during the 8 wks of EC provision Change in expired air carbon monoxide (CO) during EC provision. Change in expired air CO (ppm) from baseline to week 8 between randomized groups Change in anabasine - during EC provision. Change in urine anabasine level (ng/mL)from baseline 1 to week 8 between randomized groups |
|
Starting date |
Estimated study start date: August 2023. Estimated completion date: December 2024 |
|
Contact information |
Joanna M Streck, PhD, 617-643-9977, jstreck@mgh.harvard.edu |
|
Notes |
New to 2023 update |
|
Methods |
Design: randomized cross-over Setting: University of Kansas Medical Center, USA |
|
Participants |
Estimated enrolment: 48 Inclusion criteria: identify as non-Hispanic white or non-Hispanic African-American/black; willing to switch from CC to EC for 6 wks; smoke greater than or equal to 25 of the last 30 days for the past 3 months; not previously used an EC for > 30 days; exhaled CO of ≥ 6ppm at screener visit; willing to abstain from marijuana for 12 hours prior to in-person lab visits; willing to abstain from smoking and vaping for 12 hours prior to 3 in-person lab visits Exclusion criteria: weekly use of EC over the last 6 months; use of tobacco products other than CC on ≥ 10 days in the past 30 days; use of EC on > 5 of the past 30 days; current use of cessation medications; pregnant/breastfeeding; past 30-day hospitalization/ER visit for psychiatric issue, seizure, stroke, or new heart problem; recent history of cardiovascular or pulmonary events in the past 3 months; treatment for alcohol or drug dependence in the past yr; current enrolment in a programme aimed at changing smoking patterns Motivated to quit: not clear but excluded if using current cessation medication EC use at baseline: no |
|
Interventions |
EC: Pod. Electronic cigarette nicotine concentrations 1.8% and 5% Participants will complete 2 standardized, 10-puff vaping bouts over 5 mins followed by a 60-minute ad libitum vaping session, using 2 e-liquids that differ only by nicotine concentration (5% vs 1.8%) to examine the effect of nicotine concentration on in-lab compensatory puffing, nicotine exposure, and e-liquid consumption. In Phase 2, the same participants will be randomized to 5% or 1.8% nicotine e-liquid and instructed to switch completely for 6 weeks. African-American / White EC Nicotine Concentration Order: 1.8%, 5%, 1.8% EC Nicotine Concentration Order: 1.8%, 5%, 5% EC Nicotine Concentration Order: 5%, 1.8%, 1.8% EC Nicotine Concentration Order: 5%, 1.8%, 5% |
|
Outcomes |
Baseline lab visit 1, lab visit 2. Phase 2: 6 weeks home use Total inhaled volume. Time frame: 2 to 10 days between visits. Differences within participants in total inhaled volume in electronic cigarette puff topography during the pharmacokinetic portions of lab visit 1 and 2 Examine the impact of nicotine concentration on short-term, real-world EC use patterns and related biomarkers of exposure (e.g. exhaled carbon monoxide, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), lung inflammatory markers) AEs phase 1 and phase 2 added together. See whether data for other outcomes is presented separately for each phase . |
|
Starting date |
Starting date: 20 February 2023. Estimated primary completion date: 20 February 2025 |
|
Contact information |
Leah Lambart, MPH, 913-945-7862, llambart@kumc.edu Eleanor Leavens, PhD, 913-588-3763, eleavens@kumc.edu |
|
Notes |
New to 2023 update |
|
Study name |
A multi-site randomized actual use study of electronic nicotine delivery system (P12) products among current U.S. adult smokers to assess the relative impact of availability and use of different e-liquid flavors on changes in cigarette consumption Brief title: CSD201204 An actual use study of P12 electronic nicotine delivery system among U.S. adult amokers |
|
Methods |
Multi-site, open-label, randomized, 3-arm, 8-week, prospective observational study Setting USA |
|
Participants |
1845 participants enrolled Inclusion criteria: 21 to 60 years of age, inclusive, who are regular smokers (≥ 5 cigarettes/day on at least 20 of the past 30 days), indicate "an intention to use" (6 or higher on a 10-point Likert scale) for at least one Study IP flavour per arm across all 3 study arms. Exclusion criteria: currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within [≤] 30 days prior to pre-screening); regular ENDS user (using ENDS > 3 days per week, in the past 30 days), based on self-report; pregnant or breastfeeding; "poor" physical health; "poor" mental health; employees of a company that manufactures tobacco or ENDS products. |
|
Interventions |
Active comparator: 1. Tobacco flavour 2. Menthol flavour 3. NTNM flavour For all can choose between 2 different flavour variants at 2 different nicotine levels (1.5% and 5%). 4 options per arm. Real-life/naturalistic environments. Subjects will be able to choose freely among the Study IP available in 1 of the 3 study arms to which they are randomly assigned. The 3 study arms are organized by Study IP flavour categories: tobacco, menthol, and non-tobacco-non-menthol (NTNM). Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarettes (CC) and any other tobacco- and nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). |
|
Outcomes |
Baseline to 6 weeks Number and proportion of subjects who reduce their cigarettes per day (CPD) (over 6 weeks). Number and proportion of subjects who reduce their cigarettes per day (CPD) consumption by at least 50% at Week 6 compared to baseline among all subjects who complete the study. CPD mean per cent reduction over 6 weeks. CPD mean per cent reduction at Week 6 compared to baseline among all subjects who complete the study. |
|
Starting date |
Study start date: September 2023 Study completion 2024 |
|
Contact information |
RAI Services Company. Reynolds American. Tobacco Industry. Study Director: Kristen Jordan, PhD Contact information not provided in NCR record. |
|
Notes |
New to 2024 update |
|
Study name |
Comparison of nicotine replacement therapy and electronic cigarettes for smoking cessation in Pakistan |
|
Methods |
RCT Pragmatic, open-label, parallel design RCT Setting: Pakistan |
|
Participants |
Inclusion criteria: 18 years or older; current smokers presenting to a cessation clinic expressing a desire to quit smoking; capacity to consent; can read and understand the instructions in Urdu and/or English and follow the study instructions and procedures. Exclusion criteria: pregnant or breastfeeding ; using EC or NRT products; enrolled in another similar study; not willing to quit; have had a recent cardiovascular event like unstable angina, stroke or myocardial infarction in the past 2 weeks. Motivated to quit |
|
Interventions |
EC vs NRT EC: The intervention consists of the use of an EC device, Vaporesso Gen Air 40 Vape Kit (includes EC device, integrated battery, refillable tank, charging cable, coil replacements and user manual). Three e-liquid flavours will be provided; tobacco, menthol, and fruit flavour. All e-liquids will have a nicotine concentration of 18 to 20 mg/mL. EC will be provided for a total of 12 weeks. NRT: NRT combination therapy with a transdermal nicotine patch (7, 14, or 21 mg) and an oral product: either gum or lozenge in 1, 2, or 4 mg strength. Usage will be in the form of a daily nicotine patch and ad libitum use of the faster-acting lozenge to curb nicotine cravings. Participants will be provided with a 12-week supply of NRT. |
|
Outcomes |
Baseline, 1, 4, 8, 24, and 52 weeks Carbon monoxide (CO) validated sustained abstinence at 24, 52 weeks Self-reported 7-day point prevalence abstinence at 4, 24, and 52 weeks AEs, CPD, and product satisfaction rating, 1, 4, 8, 24, and 52 weeks post TQD Intervention cost per participant (12 wks from TQD) |
|
Starting date |
Study posted October 2023. Updated March 2024. |
|
Contact information |
Fouad Aslam, MPH, 00447494700290, projectdirector@strategichealthresearch.org.uk Aftab Ahmad, MA |
|
Notes |
New to 2024 Funding: Foundation for a Smoke Free World INC |
|
Study name |
Effects of e-cigs vs pouches on cigarette smoking and addiction Official title: Evaluating the effects of e-cigarettes versus oral nicotine pouches and product constituents (menthol flavor, nicotine concentration) on adult cigarette smoking and addiction |
|
Methods |
Randomised parallel assignment Triple-masked (participant, investigator, outcomes assessor) Setting: USA |
|
Participants |
Aim to recruit 256 adults who currently smoke CC and willing to switch Inclusion criteria: 21+ years old; English literate; currently smoking cigarettes, biochemically confirmed; not planning a smoking cessation attempt or to use smoking cessation pharmacotherapies (NRT, bupropion, varenicline) in the next month Exclusion criteria: currently using any smoking cessation services and/or pharmacotherapies; pregnant or breastfeeding; significant current medical or psychiatric condition; known hypersensitivity to propylene glycol |
|
Interventions |
EC 2.4% nicotine, menthol and tobacco flavours EC 2.4% nicotine with tobacco flavour only EC 5% nicotine with menthol and tobacco flavours EC 5% nicotine with tobacco flavour only Tobacco pouches 3 mg nicotine with menthol and tobacco flavours Tobacco pouches with 3 mg nicotine with tobacco flavour only Tobacco pouches with 6 mg nicotine with menthol and tobacco flavours Tobacco pouches with 6 mg nicotine with tobacco flavour only |
|
Outcomes |
Baseline, 4, 6 weeks; 5 visits Plan to share IPD Abstinence, biochemically verified 7-day point-prevalent abstinence from cigarettes (to week 4) CPD Cigarette dependence measured using the 4-item PROMIS® Short Form v1.0 - Smoking Nicotine Dependence for All Smokers 4a. Each item is scored from 1 to 5 with the range of scores from 4 to 20 with higher scores representing greater cigarette dependence. Use of non-combustible product. Continued use of study product (to 6 weeks). |
|
Starting date |
First posted Oct 2023. Last update posted February 2024. Starting date not stated. |
|
Contact information |
Lisa M. Fucito, lisa.fucito@yale.edu Krysten W Bold, krysten.bold@yale.edu |
|
Notes |
New to 2024 Funding: National Institute on Drug Abuse (NIDA) |
|
Study name |
Trial for harm reduction with incentives and vaping e-cigarettes Official title: Harm reduction in smokers with obesity: impact of contingent incentives and e-cigarettes |
|
Methods |
Randomised, 2x2 factorial design Setting: USA |
|
Participants |
Actual enrollment: 39. Estimated enrolment 36 Inclusion criteria: BMI ≥ 25 kg/m2; smoked ≥ 5 cigarettes/day during the past year; 21 or older; exhaled CO of > 6 ppm at baseline; willing to use ENDs for 6 weeks; daily access to a Bluetooth-enabled smartphone/tablet Exclusion criteria: planning to set a smoking quit date in the next 30 days; receiving smoking cessation treatment of any kind in the past 30 days; using EC/ ENDS > 4 days per month; hospitalized for mental illness in past 30 days; heart-related event (e.g. heart attack, severe angina) in past 30 days; resides with another person enrolled in the study; pregnant, nursing, or planning to become pregnant in the next 6 months |
|
Interventions |
Interventions: EC/ENDS: participants in active comparator groups that include ENDS will receive 6 weeks' worth of ENDS supplies. Contingent incentives: participants in active comparator groups will receive incentives that vary based on participant abstinence from smoking, measured by a carbon monoxide breath sample. No EC /ENDS: participants in active comparator groups labelled No ENDS will only receive information about the comparative risk of ENDS relative to combustible cigarettes. Non-contingent incentives. Participants in active comparator groups labelled Non-Contingent Incentives will receive compensation for each breath sample provided throughout the study, with no variation. Study arms: 1. Experimental: EC and Contingent Incentives Participants in this arm will receive information about the comparative risk of EC relative to smoking as well as 6 weeks' worth of provisions of EC and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking). 2. Experimental: No EC and Contingent Incentives Participants in this arm will receive information about the comparative risk of EC relative to smoking and will receive 4 weeks of monetary incentives for complete abstinence from smoking (after a controlled ramp down of smoking). 3. Experimental: EC and Non-Contingent Incentives Participants in this arm will receive information about the comparative risk of EC relative to smoking as well as 6 weeks' worth of provisions of EC and will receive monetary incentives for providing breath samples only (non-contingent on smoking status). 3. Experimental: No EC and Non-Contingent Incentives Participants in this arm will receive information about the comparative risk of EC relative to smoking and will receive monetary incentives for providing breath samples only (non-contingent on smoking status). |
|
Outcomes |
Baseline 4, 6, and 12 weeks At 4, 6, and 12 weeks Use of EC and CC; abstinence; CO; CC and EC dependence; questionnaire comparing CC and EC; weight assessed; motivation to change; attitudes to EC using Comparing E-Cigarette and Cigarettes (CEAC) Questionnaire. IPD: plan to share data |
|
Starting date |
October 2023 Estimated completion date: December 2024 |
|
Contact information |
Cara M Murphy, 1 (401) 203-5339, THRIVE@brown.edu |
|
Notes |
New to 2024 |
|
Study name |
A clinical trial of adaptive treatment for early smoking cessation relapse (ADAPT) |
|
Methods |
Randomised sequential assignment, open-label Setting: Alabama and South Carolina, USA. |
|
Participants |
Estimated enrolment 544 Treatment-seeking people who smoke |
|
Interventions |
NRT (patches and lozenges); varenicline. At 8 weeks some non-responders will be offered EC. Treatments free for 12 weeks Switching to a different medication: 4 weeks of the other FDA-approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4. Continued use of the same medication: 4 additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4. Switching to a harm-reduction tobacco product: 4 weeks of e-cigarette products with instructions to switch completely at Week 8. Study arms 1. Adaptive Randomization 1 (switching to another medication): people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to medication will receive 4 weeks of the other FDA-approved option, either varenicline or combination NRT, with instructions to try to quit again. 2. Non-Adaptive Randomization 1 (continued use of the same medication) : people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to the medication will receive 4 additional weeks of the same medication with instructions to try to quit again. 3. Harm Reduction Randomization 2 (switching to a harm-reduction tobacco product): people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both). After two 4-week courses of pharmacotherapy, participants who are not responding to medication will be randomly assigned to a harm-reduction group (e-cigarettes). Participants assigned to the harm-reduction group will receive 4 weeks of e-cigarette product with instructions to switch completely. 4. Non-Adaptive Randomization 2 (continued use of the same medication): people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both sequentially). After two 4-week courses of pharmacotherapy, participants that are not responding to the medication will receive 4 additional weeks of the same medication with instructions to try to quit again. |
|
Outcomes |
Baseline, 4, 8, 12, 24 weeks. 8 surveys, all assessments remote. Abstinence from CC. 7-day point prevalence abstinence. |
|
Starting date |
Posted November 2023 |
|
Contact information |
Tracy T Smith, 8438725164, smithtra@musc.edu Matthew J Carpenter, 8438762436, carpente@musc.edu |
|
Notes |
New to 2024 |
|
Study name |
E-cigarette harm reduction among PLWHA in South Africa |
|
Methods |
RCT Open-label, parallel assignment Setting: South Africa |
|
Participants |
Estimated N = 90 Inclusion criteria: adult PLWHA CC smokers; speaks Afrikaans, or Xhosa, or English; daily CC smoking (≥ 5 CPD); mobile phone; interested in reducing CC smoking but not necessarily trying to quit; receives HIV/AIDS care in one of the 8 selected clinics follow-up rates Exclusion criteria: pregnant or breastfeeding; unable to provide consent; used tobacco products other than CC in the past 2 weeks (e.g. EC, cigarillo); currently engaged in an attempt to quit CC smoking; current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent |
|
Interventions |
EC: EC VUSE "Solo" single-use pods. Nicotine - 48 mg/mL (4.8% nicotine) concentration + phone counselling + EMI texting NRT: NRT (daily patches and lozenges). NRT strength will be according to the established dosing guidelines for tobacco treatment. NRT is the standard of care in tobacco treatment and helped reduce CPD in prior trials + phone counselling + ecological momentary intervention (EMI) texting Quit Line: participants will receive referral to the existing South African Quitline. Participants will receive information to contact the Quitline if participants so choose. All groups receive counselling. Each participant will receive up to 5 motivational counselling sessions. The first session will also include orientation of EMA/EMI texting. |
|
Outcomes |
Baseline, 8 weeks, 3 months, 6 months 7-day point prevalence abstinence at 3 months. Abstinence will be verified by exhaled carbon monoxide and defined as no combustible cigarette use in the last 7 days 50% reduction in cigarettes per day (CPD), compared with baseline at 6 months, CPD will be self-reported Change in American Thoracic Society Questionnaire score Client Satisfaction Questionnaire (CSQ-8) score at 8 weeks and 3 months Percent of patients who enrol in counselling at 6 months FU rate at 3 and 6 months |
|
Starting date |
Estimated start date: Feb 2024 Estimated completion date: June 2024 |
|
Contact information |
Omar ElShahawy Omar.ElShahawy@nyulangone.org NYU Langone Health |
|
Notes |
New to 2024 |
|
Study name |
A comprehensive evaluation of tobacco-flavored vs. non-tobacco flavored e-cigarettes on smoking behavior |
|
Methods |
RCT Setting: Ohio State University Comprehensive Cancer Center, USA. |
|
Participants |
Estimated N = 1500 Inclusion Criteria: >= 21 years old; Smoke >= 5 cigarettes per day for the past year; Willing to use EC /NRT; fluent English; smartphone. Exclusion Criteria: using smoking cessation medications/NRT/seeking treatment for smoking cessation; use EC > 4 days a month; lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD); unmanaged schizophrenia; past 3 month cardiac event or distress or stroke; pregnant/breastfeeding; uncontrolled high BP; serious angina pectoris or chest pain; allergy to propylene glycol or vegetable glycerin; serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm. EC use at baseline: No (exclusion criteria: use EC > 4 days a month) Motivated to quit smoking: willing to use EC/NRT although not currently seeking help to stop smoking. |
|
Interventions |
ARM I: preferred flavoured EC ARM II: tobacco flavoured EC ARM III: NRT (nicotine patches and lozenges) All receive for 14 weeks, including a 2-week pre-switch period to become familiar with usage. All given questionnaire. Participants in all arms participate in discussions throughout the trial. |
|
Outcomes |
Baseline, 2, 6, 14 and 26 weeks Intervention for 14 weeks. Participants in all arms are followed for 12-weeks after completion of study procedures. CO week 14; CPD baseline to 26 weeks; Continued use of EC (14 weeks and 26 weeks). [Abstinence to week 14.] |
|
Starting date |
Start date: 10 April 2024. Estimated completion date: 12 April 2028. |
|
Contact information |
Theodore Wagener, Ohio State University Comprehensive Cancer Center. Theodore.Wagener@osumc.edu |
|
Notes |
Ongoing study new to 2025 update. |
|
Study name |
The role of flavor in the substitutability of e-cigarettes for combustible cigarettes among persistent smokers |
|
Methods |
RCT Between-subjects study Setting: University of Pennsylvania, Philadelphia, USA |
|
Participants |
Estimated N 210
Inclusion: > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months; 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt; Ever use of an e-cigarette; CO > 10 ppm; Not using any forms of nicotine regularly other than CC; willing to switch to EC for 6 weeks and use the assigned flavors. Exclusion: Regular use of nicotine-containing products other than CC (e.g., chewing tobacco, snuff, snus, cigars, EC, etc.); enrollment in a smoking cessation program over the duration of the study; current use of smoking cessation medication; history of substance abuse (other than nicotine dependence) in the past 12 months; pregnant/breastfeeding; serious or unstable disease within the past year (e.g. cancer, heart disease); lifetime history of schizophrenia or psychosis. EC use at baseline: no Motivated to quit: yes (have tried to quit on > 5 occasions (inclusion criteria).) |
|
Interventions |
All participants are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. Participants will receive an e-cigarette device and flavored nicotine pods according to their randomly assigned flavor. 1) EC fruit flavour (blueberry or watermelon-flavored pods) 2) EC tobacco flavour 3) EC menthol flavoured All participants provided with EC and instructed to switch from smoking CC to using only the study provided nicotine EC pods. Participants will receive their supply of nicotine pods in 7-day increments, based on baseline smoking behaviour. |
|
Outcomes |
Time Frame: 42 days (days 8 - 49). 6 months |
|
Starting date |
Start date 26 August 2024. Estimated study completion date December 2027. |
|
Contact information |
Janet Audrain-McGovern, audrain@pennmedicine.upenn.edu |
|
Notes |
New ongoing study added to 2025 update. |
|
Study name |
Noncombustible nicotine delivery systems as potential harm reduction tools for persistent cigarette smokers. Official title: Alternative nicotine delivery systems as potential harm reduction tools for persistent cigarette smokers |
|
Methods |
RCT Setting: University of Pennsylvania, Philadelphia, USA |
|
Participants |
Estimated N: 200 Inclusion: 21+; 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempts; CO) greater than 10 ppm; not using any forms of nicotine regularly other than cigarettes; willing to switch to e-cigarettes or nicotine pouches for 6 weeks. Exclusion: history of substance abuse (other than nicotine dependence) in the past 12 months; pregnant/breastfeeding; serious or unstable disease within the past year (e.g. cancer, heart disease); lifetime history of schizophrenia or psychosis. EC use at baseline: no Motivated to quit: yes, have tried to quit on > 5 occasions (inclusion criteria). |
|
Interventions |
1) EC. Tobacco, menthol, watermelon, and blueberry flavored nicotine pods. 2) Oral nicotine pouches. Original, mint, berry, and citrus flavored nicotine pouches. Instructed to use study product for 6 weeks. Receive supply of study product in 7-day increments, based on baseline smoking behavior. |
|
Outcomes |
Baseline, 49 days, 6 months. CPD baseline to the end of the six-week switch period and 6 months. Changes in biomarkers of potential harm, assessed at baseline and the end of the six-week switch phase. CO, FEF, NNAL, 1-HOP. |
|
Starting date |
Starting date 2 October 2024. Estimated study completion date 31 March 2028. |
|
Contact information |
Janet Audrain-McGovern, Professor, University of Pennsylvania. audrain@pennmedicine.upenn.edu Collaborator: National Cancer Institute. |
|
Notes |
New ongoing study added to 2025 update. |
|
Study name |
Switch or quit R01. Official title: Non-cigarette tobacco products as harm reduction tools in smokers who failed to quit with traditional methods |
|
Methods |
RCT Setting: Medical University of South Carolina |
|
Participants |
Estimated N 225 Inclusion Criteria: adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.; interest in reducing harms from tobacco use or quitting smoking Exclusion Criteria: pregnant / breastfeeding. Motivated to quit: yes, all have previously tried to quit. |
|
Interventions |
1) EC. Participants will choose between two different brands of EC and choose up to two different flavors. Participants will receive 11 weeks of EC products with instructions to switch completely at switch date. 2) Medication. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive 11 weeks of FDA approved medication with instructions to quit smoking cigarettes at quit date. |
|
Outcomes |
Baseline, 11 weeks Abstinence: Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired CO < 6 ppm. CO for all? > 50% reduction in cigarette smoking. |
|
Starting date |
Starting date: 10 July 2024. Estimated completion date 1 May 2027. |
|
Contact information |
Tracy Smith, smithtra@musc.edu. Merritt McDonald mcdoname@musc.edu |
|
Notes |
New ongoing study added to 2025 update. |
|
Study name |
Pilot randomized controlled trial of e-cigarette switching among older adults with opioid use disorder. Short title: E-cigarette switching older adults. |
|
Methods |
RCT Setting: University of Maryland Addiction Treatment Center, Baltimore, Maryland, USA |
|
Participants |
Esimated N: 40 Inclusion Criteria: 50 years or older; currently in treatment for opioid use disorder for at least 3 months; currently use CC; expired air CO 8ppm; does not regularly use EC (regular use defined as use in the past month for 2 or more consecutive days); not pregnant or breastfeeding. Exclusion Criteria: trying to stop smoking or have a plan to quit smoking; age 49 or younger; not currently using CC. Not motivated to quit smoking. Not regularly using EC. Inclusion based specific population characteristic: 50 years + and in treatment for opioid use disorder . |
|
Interventions |
1) EC (NJOY Ace, menthol or tobacco flavour depending on patient preference) + education on tobacco harms 2) Control standard advice. Brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine). Inclusdes linking to a smoking cessation quitline. |
|
Outcomes |
Baseline, 2, 6, 8 weeks CPD (self-report), intention to quit, assessments of tobacco and other substance use, health status, mood, and functioning. |
|
Starting date |
Start date 25 November 2024. Estimated completion December 2025. |
|
Contact information |
Bethea A Kleykamp, University of Maryland, Baltimore |
|
Notes |
New to 2025 update. |
|
Study name |
Harm reduction for smokers with mental illness: RCT of e-cigarette provision with or without behavioral support to boost switching |
|
Methods |
RCT Setting: 2 locations: Louisville, Kentucky USA , and Kalamazoo, Michigan USA Sponsor: Dartmouth-Hitchcock Medical Center, New Hampshire, USA |
|
Participants |
Estimated N: 250 Inclusion: Diagnostic Criteria (must have one to be eligible): Schizophrenia; Bipolar disorder; Major Depressive Disorders; Posttraumatic disorder; Other anxiety disorders. Additional Inclusion Criteria:21 years +; CC user (at least 10 cigarettes/day); At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support;Not currently interested in quitting. Exclusion: Currently residing in a nursing home; Asthma; Cognitive impairment (score <26 on the Telephone Interview for Cognitive Status (TICS); current EC use (>once a week); Psychiatric instability (hospitalized in the past month); Current AND moderate to severe substance use disorder; Pregnant; Use of any smoked products other than cigarettes; Current unstable medical illness making EC unsafe (e.g., recent heart attack, cancer); Motivated to quit: NR but have tried to quit at least once in past 5 years. No EC use at baseline. Inclusion based on specific population characteristics: people with mental illness |
|
Interventions |
1) EC NJOY for the first 8 weeks 2) EC NJOY + behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study. Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore EC options based on availability, cost, and preferences during week 4 and week 6. |
|
Outcomes |
Baseline to 8 weeks, 8 weeks to 26 weeeks NNAL, CO, Baseline to 8 weeks 8 weeks to 16 weeks CC use (self-reported). |
|
Starting date |
Start date 1 October 2024. Estiated completion date 31 March 2028. |
|
Contact information |
Meghan M. Santos, MSW, meghan.m.santos@hitchcock.org Gail Williams, MS, MFT, gail.williams@dartmouth.edu Sarah Pratt, Dartmouth-Hitchcock Medical Center |
|
Notes |
New to 2025 update. |
|
Study name |
Adaptive use of nicotine substitution to maintain smoking reduction/abstinence in nicotine responders |
|
Methods |
RCT Setting: 2 locations: Charlotte, North Carolina, USA and Raleigh, North Carolina, USA. Rose Research Center, LLC |
|
Participants |
Estimated N: 150 Inclusion Criteria: Healthy, adult CC user for ≥12 months ; CC at least 10 cpd; Screening eCO ≥ 10 ppm; aged 22 to 65 years. Exclusion Criteria: unable to understand English; history or presence of clinically significant medical or psychiatric disease; Has used nicotine EC or any NRT (nicotine patch, nicotine gum, nicotine spray, nicotine inhaler, nicotine lozenge) or prescription smoking cessation medications, including, varenicline (Chantix*) or bupropion (Zyban®) within the past 30 days; Pregnant/nursing; Participated in smoking cessation study in past year; Smokes or vapes cannabis >once a week; Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater. No EC use at baseline. Motivated to quit: NR |
|
Interventions |
To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including NRT, EC, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence. Interventions: All groups offered: Nicoderm; Nicorette 4Mg Chewing Gum; Nicorette Lozenge Product; EC NJOY; on! 1) Nicotine Non-Responders Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. 2) Nicotine Responders - Group 1 Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). 3) Nicotine Responders - Group 2 Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). |
|
Outcomes |
Baseline, week 12, 24 , 36. CC abstinence (CO confirmed) to week 24. CO to week 24. Study product use (to week 36). Cotinine to week 36. |
|
Starting date |
Start date 29 August 2024. Estimated completion date 31 December 2025 |
|
Contact information |
Derek Mercedes, derek.mercedes@roseresearchcenter.com Sponsor: Rose Research Center, LLC. Collaborator: Global Action to End Smoking |
|
Notes |
New to 2025 update. |
|
Study name |
Nicotine regulation for dual users of e-cigarettes and cigarettes (RDEC) |
|
Methods |
2x2 factorial randomized controlled trial Setting: 2 sites. Providence Rhode Island USA. Burlington, Vermont, USA. |
|
Participants |
Estimated N 308 Inclusion: regular use of tobacco; 21 year of age or older. Exclusion: Pregnant / nursing; health conditions that could undermine ability to complete the study. Inclusion based on specific population characteristics: dual users of CC and EC |
|
Interventions |
Varying the nicotine content of CC and varying the nicotine content of EC. 1) CC #1 plus EC #1 (Normal nicotine CC plus high nicotine content EC) 2) CC #1 plus EC #2 (Normal nicotine CC plus low nicotine content EC) 3) CC #2 plus EC #1 (Very low nicotine content CC plus high nicotine content EC) 4) CC #2 + EC #2 (Very low nicotine content CC plus low nicotine content EC) |
|
Outcomes |
Baseline, 12 weeks. CPD. |
|
Starting date |
Start date 1 November 2024. Estimated completion date 30 September 2028 |
|
Contact information |
Emily Booth, emily.booth@med.uvm.edu. PI Elias Klemperer. |
|
Notes |
New ongoing study added to 2025 update. |
|
Study name |
Reduce tobacco use in people living with HIV in Switzerland |
|
Methods |
Design: RCT Setting: Switzerland Population group: people living with HIV. Recruit people who use CC regardless of their willingness to quit. |
|
Participants |
Estimated enrollment: 972 Participants: People with HIV Inclusion criteria. Age 18 years or older. Smoked one or more tobacco cigarettes per day (smoking status = yes) at the time of enrolment. Signed informed consent for data collection and randomization. Exclusion Criteria: Currently using EC or nicotine pouches or nicotine patches; pregnancy. |
|
Interventions |
Menu of different tobacco smoking substitutional products (EC, nicotine pouches, nicotine patches in addition to usual of care) vs usual care Arm 1: Smoking substitution menu. Offer of preference-based smoking substitution menu, consisting of EC or nicotine pouches or nicotine patches in addition to standard of care. This menu will be offered by the treating physician during the routine cohort visit and the participant can choose one product to test as an alternative to tobacco smoking. The products will be handed out directly after the consultation and are provided free of charge for 6 months. Arm 2: Standard of care group. Standard smoking cessation counselling according to routine care in the SHCS. |
|
Outcomes |
Baseline, 6 months, 12 months, 24 months. Outcomes: CC absinence; CPD; cholesterol; blood pressure; body weight; CRF (SCORE2-risk); cardiovascular events, SAE; self-report of EC use; self-report of any nicotine product. |
|
Starting date |
Study start date: 2025-02-20. Estimated completion date: December 2027. |
|
Contact information |
Professor Matthias Briel (matthias.briel@usb.ch), Dr Christof Schönenberger (ChristofManuel.Schoenenberger@usb.ch). University Hospital, Basel, Switzerland |
|
Notes |
Study sponsor: University Hospital, Basel, Switzerland. Collaborators: Swiss National Science Foundation; Novartis Foundation for Medical-Biological Research. Added as ongoing to 2026 update. |
|
Study name |
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking (STEPS) Official title: Evaluating a tobacco harm reduction strategy among clients enrolled in substance use disorder treatment |
|
Methods |
RCT Setting: USA Study conducted at three outpatient SUD treatment programs across South Carolina. These sites include: 1) the Center for Drug and Alcohol Problems (CDAP) in Charleston, SC, 2) Behavioral Health Services of Pickens County (BHSPC) in Pickens, SC, and 3) Shoreline Behavioral Health Services in Conway, SC. the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and the Medical University of South Carolina in Florence, SC. |
|
Participants |
Estimated enrollement: 240 Inclusion: 21 years and older; at least 5 CPD for past 6 months; enrolled in outpatient SUD treatment and have an SUD diagnosis (past or current); must submit a breath CO sample of ≥ 7 parts per million at screening and a positive instant-read urinary cotinine test; have had at least one failed smoking quit attempt in their lifetime; have interest in reducing smoking, quitting smoking, or switching to a less harmful product, and; if female, agrees to use a form of birth control during the study. Exclusion criteria: any significant or unstable medical or psychiatric concern that would affect safety; current use of pharmacotherapy with smoking cessation efficacy; pregnant, breastfeeding, or trying to become pregnant; contraindicated for NRT, and; currently using an EC on 20+ days out of the past 30. Population: People who use CC and are in treatment for substance use disorder. Motivation to quit smoking: have an interest in reducing, quitting or switching to a less harmful product. |
|
Interventions |
EC, 12 week supply, with instructions to switch completely at switch date. FDA approved NRT, combination (patches and nicotine lozenges), 12 week supply, with instructions to switch completely at switch date. Counselling. Participants will recieve brief weekly counseling to support their quit or switch attempt from cigarettes. |
|
Outcomes |
Baseline, 12 weeks, 6 months Five in-person study visits and eleven virtual assessments. Outcomes: CC abstinence; acceptability of the intervention; substance use. |
|
Starting date |
Start date: 17 October 2025. Estimated completion date September 2028. |
|
Contact information |
Erin McClure, Medical University of South Carolina. Ela Williams, williela@musc.edu |
|
Notes |
Sponsor: Medical University of South Carolina. Collaborator: National Institute on Drug Abuse (NIDA). Added as ongoing to 2026 update. |
|
Study name |
Clinical Research Evaluating Smoking Cessation with E-Cigarettes and Nicotine Therapy (CRESCENT) |
|
Methods |
Design: RCT, 3 groups Masking : Single (Outcomes Assessor). Outcome assessor will not know the outcome of randomized assignment. Setting: USA |
|
Participants |
Estimated enrollment: 60 Inclusion based on specific population characteristics: individuals who smoke cigarettes with comorbid obesity (BMI ≥ 30 kg/m2). Inclusion Criteria: body mass index (BMI) ≥ 30 kg/m2 (i.e., obese); smoked ≥ 5 cigarettes/day during the past year; 21 or older (due to minimum legal age EC restrictions); exhaled CO level > 6 ppm at Baseline (BL) (to confirm self-reported smoking); willing to use EC or NRT for 8 weeks; access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables) Exclusion Criteria: received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking); currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products); hospitalized for mental illness in past 30 days; heart-related event (e.g., heart attack, severe angina) in past 30 days; residing with another person currently enrolled in the study; pregnant, nursing, or planning to become pregnant in the next 6 months; medical contraindication for study or product use (e.g., allergy to adhesives); taken prescription weight loss medication in the last 30 days. Motivated to quit: 'willing to use EC or NRT' EC use at baseline: not currently using EC or NRT more than 2 days/week |
|
Interventions |
Arm 1. EC. Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided. Arm 2. NRT combination (patch and oral). Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided. Arm 3. No Intervention: No-Product Control Condition. Participants in this condition will not receive any alternate nicotine product. |
|
Outcomes |
Baseline, 1, 2, and 3 month follow-up. CPD, CO, number of quit attempts, product acceptability, product adherance, change in weight, change in waist circumference, glucose regulation, interleukin-6, cotinine, diastolic blood pressure, systolic blood pressure. |
|
Starting date |
1 April 2025. Estimated completion date 31 May 2027. |
|
Contact information |
CRESCENT Study Research Staff, Brown University, CRESCENT@brown.edu |
|
Notes |
Sponsor: Brown University. Collaborators: National Institute of General Medical Sciences (NIGMS) Added as ongoing to 2026 update. |
|
Study name |
Electronic cigarettes as a harm reduction strategy among people with opioid use disorder on buprenorphine (SWITCH) |
|
Methods |
RCT Setting: Addiction Medicine Center, Greenville, South Carolina, United States, 29605, USA |
|
Participants |
Estimated enrollment: 90 Inclusion based on specific population characteristics: people with opiod use disorder who are taking buprenorphine Inclusion Criteria: Age ≥21 years; Smoke ≥5 CPD for ≥1 year; Daily CC smoker; Willing to switch to EC; Exhaled CO ≥6 ppm; Diagnosed with OUD; Stable on bupropion treatment; In good physical and mental health; Able to use a smartphone; Willing to participate in all study components; Able to provide informed consent Exclusion Criteria: Interested in quitting CC (contemplation stage of change); Use of EC on ≥4 of the past 30 days; Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days; Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days; Hypertension; Medical condition that would contraindicate participation; Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode; Current suicidal ideation or suicide attempt in the past year; Psychiatric hospitalization in the past year; Contemplating pregnancy, currently pregnant, or breastfeeding; Unable to speak and/or read English Motivated to quit: Exclusion criteria to be 'interested in quitting CC'. Use of EC at baseline: Exclusion criteria 'Use of EC on ≥4 of the past 30 days'. |
|
Interventions |
1. Sweet-Cooling EC + Counseling. Free 12-week supply of sweet-cooling EC liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. 2. Sweet non-cooling EC + Counseling. Free 12-week supply of sweet non-cooling EC liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. 3. Active Comparator: Tobacco-flavored EC + Counseling. Free 12-week supply of tobacco-flavored EC liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
|
Outcomes |
Baseline, 3 months, 6 months. CC abstinence, CO, CPD, exclusive EC use and no CC use, participants reporting both EC and CC use. |
|
Starting date |
Estimated start date 29 April 2026. Estimated completion date 29 June 2029. |
|
Contact information |
Irene Pericot-Valverde, PhD, iperico@clemson.edu |
|
Notes |
Sponsor: Prisma Health-Upstate. Collaborators: National Institute on Drug Abuse (NIDA) Added as ongoing study to 2026 update. |
|
Study name |
Smoking harm reduction using e-cigarettes and cytisine (SHRECC) Official title: Exploring alternative approaches to harm reduction and cessation for treatment-resistant tobacco dependence |
|
Methods |
RCT Setting: Ontario Canada. |
|
Participants |
Estimated enrollment over 4 years: 6000 STOP participants who smoke ≥5 cigarettes daily at six months post-treatment. People who continue to use CC despite standard treatments of Ontario's STOP Program (access to free NRT and counseling). Inclusion Criteria: willingness to comply with all study procedures, for the full duration of the study period (12 months); age 18 years or older; currently smoking 5 or more cigarettes daily; and must have regular access to a phone and email. Exclusion Criteria: individuals who smoke only occasionally or have quit smoking prior to the 6-month follow-up; daily or almost daily users of EC for the past 30 days; Presence of medical or psychiatric conditions that may interfere with safe participation or compliance with the study protocol, including severe cardiovascular disorders, renal impairment or respiratory conditions; known allergy or hypersensitivity to any components of the EC, e-liquids, or cytisine; pregnant or breastfeeding, or planning to become pregnant within the next 12 months; or current use of pharmacological smoking cessation aids or participation in other smoking cessation clinical trials. Motivated to quit: have been enrolled in stop smoking services before joining study. EC use at baseline: no. Exclusion criteria: 'almost daily users of EC for the past 30 days'. |
|
Interventions |
This study aims to evaluate the acceptability, feasibility, and comparative effectiveness of EC and cytisine as harm-reduction tools for individuals who continue to smoke despite standard treatments 1. EC starter kit as smoking cessation intervention. Active comparator. 2. Cytisine 28-day supply as smoking cessation intervention. Active comparator. |
|
Outcomes |
12 month follow up. CPD, voucher redemption rates. |
|
Starting date |
Estimated start date: 1 May 2026. Estimated completion date January 2028. |
|
Contact information |
Laurie Zawertailo, Centre for Addiction and Mental Health, laurie.zawertailo@camh.ca |
|
Notes |
Sponsor: Centre for Addiction and Mental Health, Ontario, Canada. Added as ongoing to 2026 update. |
LC:8-iso-PGF2a: an isoprostane
1-OHP: 1-hydroxypyrene
ACS: acute coronary syndrome
AE: adverse event
AHR: airway hyperresponsiveness
AMI: acute myocardial infarction
AUD: alcohol use disorder
AUDIT: AUDIT-C checklist terminology for alcohol dependence
BMI: body mass index
BP: blood pressure
BUP: buprenorphine
CAL: clinical attachment loss
CAR: continuous abstinence rate
CAT: Computerized Adaptive Testing OR Computer-Aided Tomography
CC: combustible cigarette
CCQ: Clinical COPD Questionnaire
CEMA: 2‐cyanoethylmercapturic acid
C-F NDS: combustion-free nicotine delivery systems
CK-MB: creatine kinase, heart specific isoenzyme
CMHT: Community Mental Health Team
CO: carbon monoxide
COPD: chronic obstructive pulmonary disease
COVID: COVID-19, disease caused by SARS-CoV-2
cpd/CPD: cigarettes per day
CRF: cardiovascular risk factors
CT: computed tomography
CVD: cardiovascular disease
CXCL9: CSCL9 (chemokine ligand 9)
DESC: DESC refers to a supportive housing project (see NCT03962660)
DNA: deoxyribonucleic acid
DSM-IV/5: Diagnostic and Statistical Manual of Mental Disorders-IV/5
EC: electronic cigarette
eCO: expired carbon monoxide
ECG: electrocardiogram
ECwN: electronic cigarette with nicotine
ECwoN: electronic cigarette without nicotine
EMI: ecological momentary intervention
ENDS: electronic nicotine delivery system
EQ-5D-5L: EuroQol 5 Dimension 5 Level
ER: emergency room
FDA: Food and Drug Administration
FEF: forced expiratory flow
FeNO: fractional exhaled nitric oxide
FEV1: forced expiratory volume
FPL: federal poverty level
FSH: follicle-stimulating hormone
FTND: Fagerström Test for Nicotine Dependence
FU: follow-up
FVC: forced vital capacity
GIF: graphics interchange format
GP: General Practitioner (Dr)
HaRTS-TRENDS: (trial name) Harm reduction for tobacco smoking with
HbA1c: haemoglobin A1C, glycosylated haemoglobin
HBsAg: hepatitis B surface antigen
HCV: hepatitis C
HDL: high-density lipoprotein
HEMA: 2-hydroxyethylmercapturic acid
HIV: human immunodeficiency virus
HMPMA: 3‐hydroxy‐1‐methyl propylmercapturic acid
HPB: Health Promotion Board
HPMA: hydroxypropylmercapturic acid
hs-CRP: high-sensitivity C-reactive protein
HTP: hydroxytryptophan
ICD-10: International Classification of Diseases, Tenth Edition
ICF: International Classification of Functioning
IL-6: Interleukin 6
iSREC: immediate standardized research e-cigarette
LDCT: low-dose computed tomography
LHC: lung health check
mCEQ: modified Cigarette Evaluation Questionnaire
MDD: major depressive disorder
MetS: metabolic syndrome
MHRA: Medicines and Healthcare products Regulatory Agency
MI: myocardial infarction
MINI: mini International Neuropsychiatric Interview
MMP9: matrix metallopeptidase 9
mMRC: modified Medical Research Council
MNWS: Minnesota Nicotine Withdrawal scale
mPES: multi-Parameter Evidence Synthesis
MPSS: mood and physical symptoms scale
MTSS: Motivation To Stop Scale
MTWS-R: Minnesota Tobacco Withdrawal Scale-R (15 items)
NHS: National Health Service
NIDA: National Institute on Drug Abuse
NNC: non-nicotine cigarette
NCCN: National Comprehensive Cancer Network
NNAL: carcinogen found in tobacco smoke (4‐(methylnitrosamino)‐1‐(3‐pyridyl)‐1‐butanol)
NNN: N'-nitrosonornicotine
NRT: nicotine replacement therapy
OHQoL-UK: Oral Health Quality of Life assessment United Kingdom
OUD: opioid use disorder
PANSS: Mean Positive and Negative Syndrome Scale
PATH: Population Assessment of Tobacco and Health
PEF: peak expiratory flow
PG: propylene glycol
PGEM: a stable metabolite of prostaglandin E2 (biomarker of inflammation)
PHQ-9: Patient Health Questionnaire 9
PI: principal investigator
PK: pharmacokinetic
PneT: PheT phenanthrene tetraol
PP(A): point prevalence (abstinence)
PPD: pocket probing depths
PROMPT: Community-Based Participatory Tobacco Dependence Strategy (PROMPT Project)
PS[E]CDI: Penn State Electronic Cigarette Dependence Index (e-cigarette dependence measure)
QN: NHS quit now programme
QoL: quality of life
q-PADDA: primer anchored DNA damage detection assay
QSU-Brief: Questionnaire of Smoking Urges
QTC: QT interval (time it takes for the electrical system to fire an impulse through the ventricles and then recharge)
RA: research assistant
RC: research cigarettes
RCT: randomised controlled trial
REDCAP: Research Electronic Data Capture (web application for surveys)
SABA: short-acting β2-agonists
SAE: serious adverse event
SC: e-salivary cotinine
SCP: smoking cessation programme
SES: socioeconomic status
SMI: serious mental illness
S-PMA: S-phenylmercapturic acid
SpO2: oxygen saturation
SREC: standardized research e-cigarette
SRMH: self-rated mental health
SSS: stop-smoking services
T2DM: type 2 diabetes
TC: tobacco cigarette
THP: tobacco heating products
TLFB: timeline follow back
TMS: transcranial magnetic stimulation
TNE: total nicotine equivalents
TNF-a: tumour necrosis factor alpha
TQD: target quit date
UC: usual care
USB: universal serial bus
V: volts
VAR: varenicline
VBA: very brief advice
VLNC: very low nicotine content
VNP: vaporized nicotine products
VO2: oxygen consumption
WBC: white blood cell
WISDM-Brief: Wisconsin Inventory of Smoking Dependence Motives-Brief
wk: week
WLC: waiting-list control
YLST: Yorkshire Lung Screening Trial
yr: year