Registered studies, protocols and reported results
Studies
Clinical study protocols and source-reported registry results, preserved locally.
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Registered studies, protocols and reported results
Clinical study protocols and source-reported registry results, preserved locally.
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Registered studies, protocols and reported results
Study registrations describe protocols. Results are shown only when the registry supplied a Results section; local links are not efficacy claims.
233 exact matches
Snapshot 01/11/2026The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-related effects between men and women The proposed study will compare smoked cannabis's dose-dependent, analgesic and abuse-related effects between men and women and variables that underlie these sex-dependent differences, including pharmacokinetics of THC.
Open study recordThe purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.
Open study recordThe goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days. 170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general. The following gain of knowledge is expected: * substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.). * substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.). * compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy. * importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance. * possible reduction of costs and improved economics through CAM
The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial. This is a single site, double-blind, randomized, pilot study of 10 participants investigating two medicinal cannabis (MC) products in children aged 6 months to 21 years who are undergoing palliative care for non-oncological conditions. Eligible participants will be randomized 1:1 to receive one of two medicinal cannabis products (C12T12 or C20T5). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomised trial of MC to reduce symptom burden in paediatric patients undergoing palliative care for non-oncological conditions. The secondary objective of this study is to collect preliminary data on the safety of two different oral MC oil formulations in this population. Each participants will be involved in the trial for up to 100 days: * Screening period: Up to 14 days * Up-titration: day 1 to day 16 * Maintenance treatment period: day 17 to day 42 * Down-titration: day 43 (end of maintenance period clinic visit) to day 58 * Post-treatment follow-up: day 59 to day 86.
Open study recordThe study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.
Open study recordMany patients with advanced pancreatic cancer and colorectal cancer experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called "symptom burden") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival. Current approaches to manage these cancer-associated symptoms often work poorly, with most patients reporting a moderate to severe symptom burden. Therefore, there is an urgent need for treatments that improve these symptoms in patients with advanced pancreatic and colorectal cancer, and data suggests that medical cannabis can help. In this research study, we are examining the usefulness of using medical cannabis in patients with advanced pancreatic cancer and colorectal cancer to further study how cannabis can impact their symptom burden. Participants will be randomized 1:1 to receive "early'' or "delayed'' medical cannabis. The early group will have access to medical cannabis immediately at no charge, while the delayed group will agree not to use cannabis of any type during the first 8 weeks. The primary study period for assessing the primary aim is 0 - 8 weeks. Participants in the early arm will have an option to receive cannabis at no charge for another 8 weeks (total 16 weeks), but will be responsible for the cost of the cannabis in this second 8 week period. Participants in the delayed arm will use cannabis from weeks 8 to 16. This secondary study period (8-16 weeks) will be used to assess the proportion of participants in the early arm who choose to continue cannabis, persistence of symptom relief with cannabis, and ongoing safety signals. Patients in the delayed group will complete patient-reported outcomes using NCI PRO-CTCAE (PRO) (weekly) and PROMIS Global (QOL) (every 4 weeks) through 16 weeks. Patients in the early group will complete PRO (weekly) and QOL (every 4 weeks) through week 8, then PRO/QOL every 4 weeks until week 16. All patients will complete a close out survey at the end of their cannabis administration period.
Open study recordThis inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.
Open study recordTo collect information about how patients in the pain management clinic use cannabis/CBD, including how often it is used, why it is used (for example, to manage pain or other symptoms), and where patients get their information on cannabis/CBD for pain management Objectives Primary Objective: The primary objective of this study is to investigate the prevalence of current and prior cannabis and/or CBD use in cancer patients who present to the pain management clinic at MDACC. Secondary Objectives: The secondary objective is to investigate the reason for cannabis/CBD use (e.g. pain, neuropsychiatric symptoms, recreational or other use), degree of symptom improvement with use, frequency of use, methods of use (e.g. inhaled vs. ingested), sources of information on cannabis/CBD, and patient interest in learning more from their physicians about cannabis/CBD for cancer pain.
Open study recordThe purpose of this activity is to identify promising cannabis warning messages from different themes. Participants will be adults who live in the United States, including both people who use cannabis and those who do not use cannabis. In an online within-subjects experiment, participants will be randomly assigned to view 7 cannabis warning messages from different themes developed as part of previous study activities. After viewing each cannabis warning message, participants will rate the message on awareness, clarity, believability, cognitive elaboration, perceived message effectiveness, and reactance. The survey will take 15-20 minutes. The purpose of this activity is to identify promising cannabis warning messages from different themes. Setting: An online survey of adults who live in the United States. Participants: An estimated N=1500 adults who live in the United States, including both people who use cannabis and those who do not use cannabis. Participants will be recruited by Qualtrics Services. Participants who are eligible for the study will view a consent form as part of the survey and check a box to indicate that they agree to participate in the study. Once the participant has completed consent, they will be able to begin the survey. Procedures: Participants will complete a within-subjects experiment in which they view and rate cannabis warning messages from different themes. Participants will be screened for inclusion and answer questions on demographic information and susceptibility to cannabis use. Participants will then be randomly assigned to view 7 cannabis warning messages from different themes developed as part of previous study activities. After viewing each cannabis warning message, participants will rate the message on awareness, clarity, believability, cognitive elaboration, perceived message effectiveness, and reactance. There will be a total of 11 warning themes plus control. After viewing and rating their assigned cannabis warning messages, participants will answer additional questions about cannabis risk perceptions and use behavior (if applicable), additional demographic information, and about their use of tobacco and alcohol. The survey will take 15-20 minutes.
Open study recordThis outpatient study examines how inhaled cannabis, combustible or vaporized, alters lung health and breath biomarkers compared to a tobacco cigarette.
Open study recordThis study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly. This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.
Open study recordPhase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue. The ancient Ayurvedic medicine obtained from Cannabis sativa plant has recently been re-explored for its anti-inflammatory and anti-cancer potential. Various laboratory and preclinical studies have proven its anti-cancer activity and its effect on all the hallmarks of cancer. Anecdotal clinical evidence has shown regression of tumours with ingestion of such medicinal cannabis. A randomized controlled trial in Glioblastoma Multiforme, a kind of brain tumour, shows improvement in disease free survival when temozolamide was combined with Cannabis spray called Sativex. However, because of lack of systematic, large volume studies, the evidence is slow to emerge. We have previously seen changes related to NF-kb (inflammation) and AP1 (acute hypoxia/stress) pathway genes within the tumour tissue as assessed by transcriptomic analysis (Yet unpublished data). There is laboratory evidence to suggest that the changes induced in the AP1 pathway during surgery can be ameliorated by cannabis treatment. We intend to explore this anticancer potential of C sativa herbal preparation in the pre-operative setting in breast and head and neck cancer patients. Hence, we are proposing a phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.
Open study recordThe present study will characterize the ability of pregnenolone to reverse the acute intoxication and associated symptoms of cannabis. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). By clarifying the ability of pregnenolone to reverse cannabis intoxication symptoms, this study will pave the way for larger clinical studies that provide a foundation for the development of future CB1-receptor NAM medications that could be applied in emergency situations and potentially validate pregnenolone as a treatment for cannabis intoxication. This human laboratory study will characterize the ability of pregnenolone to reverse the acute cannabis intoxication using measures of subjective drug effects, cardiovascular responses, and cognitive performance. Participants (n=16) will complete four double-blind, randomized, outpatient sessions. In each session, participants will self-administer cannabis containing either 0 mg THC (placebo) or 25 mg THC (active) via an oral route of administration. Ninety minutes after cannabis administration, participants will self-administer two oral capsules containing either 0 mg pregnenolone or 250 mg pregnenolone for a total of either 0 mg, 250 mg, or 500mg pregnenolone. Assessments will include subjective drug effect instruments, a battery of cognitive and psychomotor performance tasks, and physiological measures. Sessions will be conducted at a target rate of once per week. Results from this study of pregnenolone could have far-reaching clinical implications: not only would results provide conceptual support for NAMs as treatments for cannabis intoxication but may posit pregnenolone itself as a novel pharmacotherapeutic that could reduce the burden of ineffective and potentially harmful medications currently used in the treatment of cannabis intoxication in emergency settings. If pregnenolone is shown to be effective, additional drug development can be done to determine the best formulation, dose, and route of administration for maximal clinical benefit. Should pregnenolone not reverse THC intoxication completely, development of analogs with greater efficacy can be explored.
Open study recordThis clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety. PRIMARY OBJECTIVES: I. Assess pharmacokinetic (PK)/pharmacodynamic (PD) profiles of THC vaping liquids administered with co-use of vaped nicotine. II. Outcomes of interest will be assessed overall, and according to biological sex. SECONDARY OBJECTIVES: I. Safety. II. Assessment of differences in puffing behaviors. III. Short-term subjective drug effects, and cognitive performance following THC use without nicotine versus (vs.) THC use with pre-nicotine use vs. THC use with post-nicotine use in current consumers of both vaped cannabis and vaped nicotine products. OUTLINE: Participants are randomized to 1 of 3 arms. ARM A: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 2: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. ARM B: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. ARM C: Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 3: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial. After completion of study intervention, participants are followed up at 30 days.
Open study recordPsoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context. This study aims to evaluate the effects of oral and topical cannabinoid administration in patients with psoriasis over a 180-day period. Oral administration will be performed using a full-spectrum extract containing CBD:CBG:THC in a 1:1:1 ratio, with a concentration of 20 mg/mL of each cannabinoid. Dose titration will be conducted progressively according to individual tolerability. The dosing schedule will follow a stepwise escalation: 0.08 mL/day in the first week (approximately 1.6 mg/day of each cannabinoid), 0.17 mL/day in the second week (approximately 3.3 mg/day of each cannabinoid), and 0.25 mL/day in the third week (5 mg/day of each cannabinoid). From the second month onward, the dose will be increased to 0.5 mL/day (10 mg/day of each cannabinoid), defined as the maximum study dose, and maintained until the end of the intervention period. Topical administration will be performed using a cream containing CBD:CBG:THC, in the same proportion as the oral extract, with a concentration of 20 mg/mL of each cannabinoid. The product will be applied directly to psoriasis lesions twice daily throughout the study period. No titration will be performed for the topical formulation, and a fixed-dose regimen will be maintained. The study will follow a two-phase design. Participants will be initially allocated into two groups: Group 1 (oral) will receive the oral extract for the first 60 days, while Group 2 (topical) will use the topical formulation during the same period. In the second phase (days 60-180), all participants will receive combined treatment (oral extract plus topical formulation). This design allows evaluation of both isolated and combined therapeutic effects.
Open study recordChronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication, and they report experiencing minimal psychoactive effects. However, there are few well-controlled human laboratory studies assessing cannabis' efficacy for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability. Carefully controlled research is needed. The proposed within-subjects, placebo-controlled 16-day crossover inpatient human laboratory study (N = 20 healthy cannabis users; 10 men, 10 women) will address three important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) Does tolerance develop to repeated, daily smoked cannabis administration on measures of experimental pain and abuse liability; 2) If so, is tolerance reversed during the 7 days of abstinence from active-THC cannabis; 3) Does abrupt abstinence from active cannabis increase experimental pain sensitivity, i.e. hyperalgesia, relative to baseline, and do these effects parallel measures of cannabis withdrawal such as disrupted mood and sleep? Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS). Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.
Open study recordThis study will evaluate the subjective and behavioral effects of cannabis products labeled as indica, sativa, or generic. This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 6 outpatient drug administration sessions that will consist of self-administration of smoked cannabis (0, or 25mg THC) labeled as indica, sativa, or generically-labelled. Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, and simulated driving performance. Smoking topography will also be characterized.
Open study recordThis human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states). This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 7 experimental drug administration sessions in randomized order where the participant will vaporize cannabis-containing capsules (or "pods") (containing 0, 5, or 25mg THC) with a drink that contains no alcohol or alcohol (alcohol-containing drinks will be calculated to produce a breath alcohol concentration, BAC, of 0.05%). There is also a positive control session where participants will vaporize placebo cannabis with an alcohol drink calculated to produce a BAC of 0.08%. Each session will last approximately 8 hours and will be separated by at least 48 hours to allow for sufficient drug washout. Participants may complete up to 2 sessions per week. Drugs will be administered in a double-blind and double-dummy fashion (i.e., participants will always receive both active or placebo cannabis and active or placebo alcohol). During each session, a battery of assessments including blood collection, subjective questionnaire administration, cognitive performance testing, and simulated driving will be conducted.
Open study recordThe goal of this observational study is to learn how medical cannabis (MC) affects pain and the use of opioid pain medications. Participants who have chronic pain and use prescribed opioid pain medication will opt-in to using MC or not for the 3-month study. Participants who are certified in Pennsylvania will purchase specific medical cannabis products at a reduced cost from a partnering medical cannabis dispensary monthly. All participants will complete baseline, daily, and monthly assessments to observe changes across groups. The primary aim is to observe if individuals who have chronic pain that they are treating with opioids and medical cannabis report changes in pain severity, function, and opioid use compared to those who do not use medical cannabis. Secondary aims include observation of whether the use of medical cannabis differentially impacts tolerability (side effects, risk of cannabis use disorder), sleep-related symptoms, or quality of life and mental health among chronic opioid users. There will be two groups, participants who are certified to use medical cannabis and those who do not use any cannabis. All participants will complete a baseline survey to report demographics, pain, sleep, mental health, well-being, quality of life, and use of medications. Some of these questions will be repeated monthly. Participants will also receive a link via text to a daily survey to report daily prescription opioid use and medical cannabis use (if applicable) as well as pain severity and interference. Participants who purchase medical cannabis at Ethos will be randomized and restricted to one formulation of medical cannabis (vaporization or tincture) for the study duration. They will purchase three different compositions of the specific medical cannabis formulation at a reduced cost over 3 months and the order of those compositions will be randomized. They will purchase one composition per month and they will not know which one they are purchasing. The three different compositions are: * A composition that is predominantly THC (tetrahydrocannabinol) * A composition that is predominantly CBD (Cannabidiol) * A composition that is a one-to-one blend of THC and CBD
Open study recordThe randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market. This project consist of two parts: The first part is a randomised controlled study, the second part is an observational study. The randomised controlled study will last six months. Participants will randomly be assigned to one of two groups: Group 1 has immediately access to regulated cannabis in pharmacies; Group 2 has to wait for six months. After six months all participants will have access to regulated cannabis in pharmacies (oberservational study). Every six month participants will be invited to answer online-questionnaires on their cannabis consumption behavior, their mental and physical health. The entire study lasts 2.5 years.
Open study record