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.
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Snapshot 14/09/2026Genetic Epidermolysis Bullosa
Open study recordPain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.
Open study recordPain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
Open study recordEvaluation of efficacy of AP707 as add-on treatment in patients with chronic pain due to central Neuropathy of any Genesis
Open study recordEvaluation of efficacy of AP707 as add-on treatment in patients with chronic pain due to traumatic or post-operative peripheral Neuropathy
Open study recordChronic painful HIV-associated neuropathy
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 recordChronic pain disproportionately affects women and may coexist with impaired bone health, particularly during midlife and after menopause. The endocannabinoid system is involved in pain modulation and bone homeostasis; however, clinical studies that integrate pain outcomes, bone-related biomarkers, genetic variants, and salivary endocannabinoids remain limited.This randomized, triple-masked, placebo-controlled crossover trial will evaluate the effects of a full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 on chronic pain in women aged 45 to 80 years with chronic pain refractory to conventional treatment. Eighty participants will be randomly assigned to one of two treatment sequences: full-spectrum cannabis extract followed by matching placebo, or matching placebo followed by full-spectrum cannabis extract. The treatment periods, washout interval, and visit schedule will follow the final approved protocol.The primary outcome is change in chronic pain intensity measured using the Visual Analog Scale. Secondary outcomes include quality of life, sleep quality, functional impact, bone health biomarkers, bone mineral density measured by dualenergy X-ray absorptiometry, salivary endocannabinoids, the association of CB and TRPV genetic variants with treatment response, and adverse events. The study aims to generate evidence on the clinical effects and biological correlates of medicinal cannabis therapy in women with chronic pain. This is a randomized, triple-masked, placebo-controlled crossover clinical trial conducted in women aged 45 to 80 years with moderate to severe chronic pain that has persisted for at least 3 months and has not responded adequately to conventional pharmacological or non-pharmacological treatments. Participants will be randomlyallocated in permuted blocks to one of two treatments sequences. Sequence A will receive a full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 during the first treatment period, followed by a protocol-defined washout interval and matching placebo during the second treatment period. Sequence B will receive matching placebo during the first treatment period, followed by the washout interval and the full-spectrum medicinal cannabis extract during the second treatment period. The study product will be administered orally as softgel capsules. The target daily dose is 25 milligrams of cannabidiol and 5 milligrams of tetrahydrocannabinol. Dose titration during the first 2 weeks of each active treatment period will follow the final approved protocol.Participants, care providers, investigators, and outcome assessors will remain masked to treatment assignment as operationally applicable. Randomization will use a computer-generated sequence with permuted blocks of 4 and allocation concealment through opaque, sealed envelopes. The product and matching placebo will be supplied in indistinguishable presentations.Clinical evaluations will include pain intensity, quality of life, functional impact, sleep quality, concomitant medications, adherence, and adverse events. Laboratory assessments will include safety tests, selected bone metabolism biomarkers, inflammatory markers, and oxidative stress biomarkers. Bone mineral density and body composition will be assessed using dualenergy X-ray absorptiometry at protocol-defined baseline and final visits. Genetic analysis will evaluate CB and TRPV variants. Salivary anandamide, 2-arachidonoylglycerol, palmitoylethanolamide, and oleoylethanolamide will be quantified using liquid chromatography coupled with tandem mass spectrometry according to the final sample collection schedule.The primary efficacy analysis will compare pain outcomes across cannabis and placebo treatment periods while accounting for the crossover design. Secondary analyses will evaluate changes in patient-reported outcomes and biomarkers, treatment safety, and associations between genetic variants or salivary endocannabinoid profiles and treatment response.
Open study recordThe goal of this clinical trial is to evaluate whether a culturally adapted, virtual, group-based emotional therapy called Emotional Awareness and Expression Therapy is feasible and whether it can help reduce chronic pain and improve emotional well-being among Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Participants will attend a weekly 1.5-hour virtual group therapy session for 8 weeks, except for the first session, which will be held in-person at the hospital's clinic. The participants will take part in group discussions and emotional processing exercises, complete questionnaires about pain levels, mood, sleep, and quality of life, and continue their usual medical treatment as prescribed by their doctors. The rising prevalence of chronic pain conditions poses a significant challenge to societies and healthcare systems globally. Despite medical advancements, many individuals continue to face chronic pain daily, with only limited success in alleviating pain and enhancing physical and emotional well-being. Faced with these challenges, numerous individuals with chronic pain have experimented with medical cannabis as an alternative form of pain management. Furthermore, the psychological burden associated with chronic pain highlights the critical need for integrating psychological support within chronic pain treatment strategies. Emotional Awareness and Expression Therapy (EAET) has demonstrated considerable reductions in pain and improvements in psychological conditions such as depression and anxiety among adults with various types of chronic pain. However, the EAET intervention has never been tested in patients treated with medical cannabis and has not yet been evaluated in Israel. Our preliminary pilot trial culturally adapted the EAET protocol into Hebrew and evaluated it in a face-to-face format. In the subsequent phase, the program will be delivered in a virtual format, rather than in person, based on insights derived from the pilot study. This study aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, eight-session, group-based virtual EAET-Hebrew intervention through a feasibility trial. The primary outcome is pain severity. The secondary outcome measures that will be assessed in this study are: pain interference and disability, pain catastrophizing, fear and pain beliefs, mood and satisfaction with life, physical functioning and quality of life, sleep and fatigue, global impression of change, health service utilization, and cannabis consumption. Description of the intervention: An innovative psychological treatment, EAET is a psychotherapeutic approach that emphasizes the role of emotional processing of unresolved trauma, stress, and conflict in the treatment of chronic pain and somatic symptoms. The intervention will be delivered as a 1.5-hour virtual weekly group session over a period of 8 weeks, although the first session will be held in-person at the hospital's clinic. Each session will include two parts, theoretical and practical, and will combine group discussion and the sharing of experiences. The study will take place at "Reuth" Rehabilitation Hospital, Tel Aviv. Patients with chronic musculoskeletal pain who are also medical cannabis consumers and are treated at the pain and cannabis clinics will be recruited for the study. Following completion of this research, a well-defined protocol for a virtual group-based EAET program in Hebrew will be developed, tailored to the Israeli context with culture-specific norms and beliefs to meet patients' unique needs effectively. This research aims to provide clear insights into the feasibility and preliminary efficacy of the adapted program through a rigorous feasibility pilot trial. This step marks the first instance in which this innovative approach, found to be superior to traditional cognitive-behavioural therapy treatments, is tested among pain patients who are treated with medical cannabis and in Israel. It is expected to reduce pain levels and disability while alleviating the mental strain experienced by patients, areas that are currently inadequately addressed. The anticipated result is a major advancement in the existing chronic pain treatment paradigm in Israel, incorporating a significant psychological component and capitalizing on the benefits of group therapy in a virtual format that is accessible to patients.
Open study recordThe investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial. Chronic pain is defined as pain lasting longer than three months, affects \~20% of Canadian adults. In addition to having a significant negative impact at the individual patient level (i.e., decreased quality of life and functioning), chronic pain is also a main cause of disability and health care use. Opioids are frequently prescribed to manage chronic pain despite limited data on their long term usefulness and has become one of the major contributors to the current opioid crisis in Canada. Chronic pain can potentially be treated with medical cannabis as an adjunct or alternative to opioids due to their similar behavioral, anatomical and biochemical mechanisms. Cannabinoids also potentially prevent the development of tolerance to opioids when co-administered. Cannabinoids have demonstrated the ability to reduce pain as well as opioid-sparing effects in pre-clinical and clinical studies however further research is needed to identify the optimal make-up, ratio, and dosage of cannabinoids to minimize harms and maximize benefits. Furthermore, studies conducted to date have methodological problems such as short follow-up windows (hours or days) that limit conclusions. The investigators therefore propose a randomized, placebo-controlled trial of oral cannabinoids \[CBD (cannabidiol) alone or in combination with THC (delta-9-tetrahydrocannabinol)\] for reducing pain disability and opioid use for pain management in chronic pain. However, there are a number of feasibility issues that should be addressed prior to launching a full-scale trial in this area. Some issues have been identified in the literature (e.g., success of blinding) while others are related to the changing socio-medico-legal landscape surrounding cannabis use in Canada. The purpose of this pilot study is to test the study plan, patient recruitment and compliance with the study procedures. Results of this study may be used as a guide for larger studies and will help us determine if medical cannabis can reduce daily opioid doses and/or decrease pain interference (disability) in chronic pain patients. This study will aim to recruit 51 patients from the Toronto General Hospital Transitional Pain Service. Study Procedure: After obtaining the Informed consent, patients will be randomized into one of the three study groups. Patients will either receive CBD oil, CBD+THC oil or placebo orally for 12 weeks. Starting dose will be 1 ml per day. The dose of study drug will be adjusted based on patients' reported efficacy and adverse effects. After starting the study drug, patients will have scheduled study visits either remotely or in-person at 4, 8, and 12 weeks plus a follow up calls or virtual clinic visit(OTN) at 2 and 6 weeks. At every study visit, patients will be asked to complete the questionnaires that will assess their pain level and how it affects their quality of life, opioid use, and side effects if they are experiencing. The investigators will also collect information on: demographic and baseline characteristics (e.g., sex, age, height, weight, and body mass index) and medical history (including prior and concomitant medications) via patient interview or from inspection of medical records. Additionally, symptoms of depression and anxiety will be measured with the validated screening tools at baseline and 12 weeks post-treatment.
Open study recordThe primary objective of this phase 2 study is to investigate the therapeutic potential of orally administered combined delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in relieving both pain and cue-induced opioid craving in people with co-occurring opioid use disorder (OUD) and chronic pain who are undergoing methadone therapy. This phase 2 study will utilize a rigorous double-blind, placebo-controlled, crossover experimental design. We will enroll 147 participants with co-occurring OUD and chronic pain who are receiving methadone maintenance treatment and randomize them into three groups (n=49). Across three test sessions, each group will receive single doses of THC (5 mg, 10 mg, or placebo) and CBD (300 mg, 600 mg, or placebo) in a 3x3 design, with THC dose as a between-subject (parallel-group) factor and CBD dose as within-subject (crossover) factor. All three groups will undergo otherwise identical procedures to ensure internal validity. Our central hypothesis posits that, combined, THC and CBD will be more effective in alleviating pain and cue-induced opioid craving than either drug alone. While THC's analgesic effects may benefit those with co-occurring OUD and chronic pain, its abuse potential and cognitive/psychomotor deficits require careful dose consideration. Combining THC with non-hedonic and neuroprotective CBD could offer a compelling two-pronged approach to alleviate both pain and opioid craving. This study will also explore if sex influences the responses to THC and CBD, given the growing evidence indicating sex-specific effects of cannabinoids and pain responses. If our hypothesis is confirmed, selected THC/CBD doses may serve as a novel, dual-action therapy to alleviate both pain and opioid craving in co-occurring OUD and chronic pain.
Open study recordThis study will assess cognition, neural function, and drug exposure in chronic pain patients who have been prescribed medical cannabis and will differentiate outcomes based on use of specific CBD-dominant versus THC-dominant treatment products. This longitudinal study will recruit medical cannabis users from local dispensaries. Each participant will complete a baseline assessment prior to the start of medical cannabis use, monthly phone calls to assess treatment adherence, and a four-month follow- up assessment. The aims of this project are: Aim 1. To assess impacts of medical cannabis compounds on executive functions, learning and memory in adults to determine whether cognitive impairments are evident after the onset of cannabis use; Aim 2. To assess the impacts of medical cannabis compounds on white matter microstructure, functional brain activity and functional connectivity; Aim 3. To differentiate change over four months in these outcomes as a function of (a) age and (b) pre-to-post-treatment changes in blood levels of cannabinoid compounds. This project was submitted to NIH in response to NOT-DA-22-003, Public Health Research on Cannabis. The overarching aim is to assess cognition, neural function, and SUD risk in a sample of patients treated with medical cannabis products in Minnesota (n=120) as compared to non-cannabis using controls (n=60) and to differentiate outcomes based on prescribed doses and blood concentrations of THC versus CBD as objective measures of drug exposure. Patients will be aged 35-65 and qualified for medicinal cannabis treatment in Minnesota due to diagnoses of chronic pain. While deficits in learning, memory and executive functions are reliably observed in young adult recreational cannabis users, it is unclear whether similar impairments characterize individuals who use cannabis for medical reasons, whether adults may be uniquely vulnerable to cannabis-related impairments or if, in fact, use in this age group might be neuroprotective. There are very few published studies of medical cannabis users that comprehensively focus on neurobehavioral outcomes even though at least 5 million people are registered for medical cannabis treatment in the United States. The current study will address this gap through a pre-post assessment of users as compared to matched controls (pain patients who do not use cannabis). Participants will be recruited through posted advertisements and through dispensaries via a collaboration with a local supplier of medical cannabis. They will complete a comprehensive pre-treatment behavioral assessment as well as multimodal brain MRI assessments. All measures will be repeated after four months of treatment. Participants will be interviewed monthly by phone in the interval between visits to assess treatment adherence, pain levels, quality of life, and substance use. Blood cannabinoid levels will be measured at baseline and after four months and will be correlated with behavioral and neural outcomes. The three aims are (1) To assess impacts of medical cannabis compounds on cognition and behavior in otherwise cannabis-naive adults to determine whether impairments that characterize younger users are evident after the onset of medical cannabis use; the investigation will also measure treatment-related changes in pain using well-validated measures. (2) To similarly assess the impacts of medical cannabis compounds on white matter microstructure, functional brain activity and functional connectivity using diffusion-weighted scans, task-based fMRI, and measures of resting state connectivity; (3) To differential change over time in these outcomes as a function of (a) exposure to distinct cannabinoids (THC vs. CBD) as assessed through blood concentrations and (b) age. Sex as a biological variable will be assessed as a covariate of interest. Thus, this proposal will yield a rich dataset through which medical cannabis effects on adults' neurobehavioral function can be assessed and contrasted with the literature on non-medical users.
Open study recordThe goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. All study interactions will be done virtually and recruitment data is exploratory.
Open study recordPosttraumatic stress disorder (PTSD) occurs in approximately 7% of adults in the general population. PTSD greatly impacts quality of life and often co-occurs with other conditions such as chronic pain. Individuals with co-morbid PTSD and chronic pain demonstrate higher PTSD symptoms and pain (as well as greater anxiety, depression, disability, and opioid use) compared to those with only one of those conditions. Gold standard treatments exist for both PTSD (e.g., Prolonged Exposure; PE) and chronic pain (e.g., Cognitive Behavioral Therapy for Chronic Pain; CBT-CP) and are generally offered sequentially (i.e., one at a time for the condition that is most prominent). Treating these conditions separately may overlook their interconnected nature, which may reduce efficacy and increase dropout. Thus, there is a need for an intervention to target both simultaneously, which may be more effective and efficient than treating conditions sequentially. This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and chronic pain. The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment draws from modules in PE and CBT-CP including psychoeducation, exposure to feared/avoided situations and activities, processing of exposures, behavioral activation, breathing and relaxation techniques, sleep hygiene, symptom monitoring, and structured homework assignments. Baseline and post-treatment assessments will be conducted.
Open study recordThe goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. All study interactions will be done virtually.
Open study recordThis research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain. Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period. The study hypotheses: \- CBD would improve overall pain symptoms compared to placebo
Open study recordThe goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Researchers will compare patients who receive the emotional therapy along with their usual care to patients who receive usual care only, to see if the therapy leads to better outcomes in pain, mental health, and daily functioning. Participants will attend a weekly 1.5-hour group therapy session for 8 weeks; Take part in group discussions and emotional processing exercises; Complete questionnaires about pain levels, mood, sleep, and quality of life; Continue their usual medical treatment as prescribed by their doctors. The rising prevalence of chronic pain conditions poses a significant challenge to societies and healthcare systems globally. Despite medical advancements, many individuals continue to face chronic pain daily, with only limited success in alleviating pain and enhancing physical and emotional well-being. Furthermore, the psychological burden associated with chronic pain highlights the critical need for integrating psychological support within chronic pain treatment strategies. Emotional Awareness and Expression Therapy (EAET) has demonstrated considerable reductions in pain and improvements in psychological conditions such as depression and anxiety among adults with various chronic pain types. However, the EAET intervention has never been tested on patients treated with medical Cannabis and has not yet been evaluated in Israel. Furthermore, we propose that adapting the EAET program to reflect local cultural perspectives on pain and its management will be essential for its effective implementation among Israeli patients. This study aims to culturally adapt the Emotional Awareness and Expression Therapy - Hebrew (EAET-H) eight-session group-based protocol, for Israeli patients with chronic pain receiving medical Cannabis. The study includes a culturally adaptation of the EAET-H according to the steps outlined by Escoffery and colleagues and fidelity assessment through a single-arm pilot trial, which will assess its implementation fidelity, feasibility, acceptability, and preliminary efficacy on pain severity compared to the usual care. The secondary outcome measures that will be assessed in this study are: pain interference and disability, pain catastrophizing, fear and pain believes, mood and satisfaction with life, physical functioning and quality of life, sleep and fatigue, global impression of change, health service utilization and cannabis consumption. Description of the intervention: An innovative psychological treatment, EAET is a psychotherapeutic approach that emphasizes the role of emotional processing of unresolved trauma, stress and conflict in the treatment of CP and somatic symptoms. The intervention will be delivered as a 1.5-hour weekly group session for a period of 8 weeks. Each session will include two parts, theoretical and practical, and will combine group discussion and sharing experiences. The study will take place at "Reuth" Rehabilitation Hospital, Tel- Aviv. Chronic musculoskeletal pain patients who are also medical cannabis consumers, treated at the pain and cannabis clinics will be recruited for the study. Following completion of this research, a well-defined protocol for a group-based EAET program in Hebrew will be developed, tailored to the Israeli context with culture-specific norms and beliefs to effectively meet patients' unique needs. This research aims to provide clear insights into the feasibility and preliminary efficacy of the adapted program through a rigorous pilot trial. This step is marking the first instance this innovative approach, found to be superior to traditional cognitive-behavioural therapy treatments, is tested among pain patients who are treated with medical Cannabis and in Israel. It is expected to significantly reduce pain levels and disability while alleviating the mental strain experienced by patients-areas currently inadequately addressed. The anticipated result is a major advancement in the existing chronic pain treatment paradigm in Israel, incorporating a significant psychological component and capitalizing on the benefits of group therapy.
Open study recordMedical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients, cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, prior to receiving medical cannabis. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted. Opioid use for pain has increased drastically over last decade with disastrous results that lead to an epidemic of overdoses and deaths in the United States. Philadelphia has been described as "ground zero" in the opiate epidemic of overdoses and deaths in the United States. Some initial clinical experience shows that medical marijuana can potentially assist patients suffering from certain serious medical conditions by alleviating pain and improving quality of life, allowing them to discontinue opiates. Medical Cannabis is very safe and a viable option for pain relief to improve patients and their family's quality of life. The medical marijuana law in Pennsylvania was passed in 2016 with the hope that this might alleviate the opiate crisis. The opioid death rate in Pennsylvania was 37.9 per 100,000 people. However, medical cannabis is not covered by insurance and is an out of pocket expense. This has been a barrier to some patients trying medical cannabis as an alternative. This can create a disparity in care of chronic pain patients. Methods: Recruitment and inclusion/exclusion criteria: Potential participants will be recruited from an outpatient chronic pain clinic. 40 patients who have agreed to attempt wean down on opioid medication and have a diagnosis which qualifies them for medical marijuana will be selected for the study. In these selected patients cost of the treatment was the main barrier for starting medical cannabis. Each participant will undergo a urine drug screen, a pain assessment using the visual analog scale and pain quality will be assessed using the Short Form-36 health related quality, which measures sensory, affective and evaluative dimensions of pain prior to receiving medical cannabis and then at 5 months. Each patient will be evaluated by a physician who is certified to evaluate patients for Medical Cannabis. If the patient qualifies for Medical Cannabis the next step is for the patient to register on the state of Pennsylvania medical marijuana website. Medical conditions that qualify patient in the states of Pennsylvania for medical marijuana are Amyotrophic lateral sclerosis, Cancer, Crohn's disease, multiple sclerosis, Neurodegenerative diseases, neuropathies, chronic or intractable pain of neuropathic origin. After the patient registers the physician will also certify them on the website. After the patients are certified they will apply for medical marijuana card. Once the patient receives a medical marijuana card the patient will start an opioid weaning plan. Each patient will have an individualized plan for weaning off their opioids which is their standard care plan. The patient will go to the select medical cannabis dispensary and will be able to choose their medical cannabis product. The Curaleaf medical cannabis dispensary will have a list of patients and participants will be able to choose from the cannabis products. The patient will be followed up monthly for five months by physician and will assess the patient's pain levels and Medical Cannabis doses and opioid doses monthly. The investigators will also note the patient side effects, tolerance and any decrease in symptoms. At five months the physician will recheck a urine drug screen, current pain level and readminister the Short form-36 health related quality. The Medical Cannabis doses and strains will be noted.
Open study recordThis exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study. Musculoskeletal pain can be due to an injury to the bones, joints, muscles, tendons, ligaments, or nerves, which can be caused by jerking movements, car accidents, falls, fractures, sprains, dislocations, and direct blows to the muscle. Musculoskeletal pain can be localized in one area, or widespread. Lower back pain is the most common type of musculoskeletal pain. Other common types include tendonitis, myalgia (muscle pain), and stress fractures. A review of opioids for non-cancer musculoskeletal diseases concluded that opioids were "only slightly more effective than their placebos, no more effective than acetaminophen, and somewhat less effective than nonsteroidal anti-inflammatory drugs. In fact, the Centers for Disease Control (CDC) recommends that opioids should not be considered an option for chronic musculoskeletal pain. The impact of cannabinoid treatments on pain in human volunteers has been evaluated for: 1) experimentally induced acute pain, 2) acute postsurgical pain, and 3) chronic pain. Collectively, these data suggest that cannabinoids may be more effective for chronic rather than acute pain conditions. However, there have been few randomized, double-blind, placebo-controlled clinical trials (RCTs, the "Gold Standard" in intervention-based studies) of cannabinoids for pain. To this end, the proposed study will contribute to the evidence base concerning the potential utility of treating chronic low back pain (cLBP) with cannabinoids. Four RCTs in 159 patients with fibromyalgia, osteoarthritis, chronic back pain, and rheumatoid arthritis treated with oral cannabinoids (nabilone, THC/cannabidiol (CBD), and fatty acid amide hydrolase (FAAH) inhibitor, placebo, or active control (amitriptyline), were included in a systemic review. The results were inconsistent and did not reveal whether the cannabinoids were superior to the controls (placebo and amitriptyline). The authors concluded that there is insufficient evidence for the recommendation for cannabinoid use for pain management in patients with rheumatic diseases. Since then, a Phase II RCT (65 participants) found no difference between THC and placebo in reducing pain measures in patients with chronic abdominal pain due to surgery or chronic pancreatitis. A more recent systematic review and meta-analysis aimed to "analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic, non-cancer-related pain". Thirty-six trials (4006 participants) were included, examining smoked cannabis (4 trials), oromucosal cannabis sprays (14 trials), and oral cannabinoids (18 trials). Of the 18 trials that examined oral cannabinoids, 15 examined synthetic THC in the form of dronabinol (n=9), nabilone (n=4), or nasimol (n=2). Treatment durations ranged from 1 day to 6 months. Across the 29 trials (34 comparisons) that had reported on pain outcomes, there was a significant treatment effect favoring the use of cannabinoids over placebo (-0.63, 95% confidence interval (CI), -0.85 to -0.42, I2 = 16%, P \< 0.00001). Compared with placebo, cannabinoids showed a significant reduction in pain, which was greatest with treatment duration of 2 to 8 weeks (weighted mean difference on a 0-10 pain visual analog scale -0.68, 95% CI, -0.96 to -0.40, I2 = 8%, P \< 0.00001; n = 16 trials). Across all time points, oral formulations demonstrated a superior effect compared with oromucosal and inhaled routes of administration. Serious AEs were rare, and similar across the cannabinoid (74 out of 2176, 3.4%) and placebo groups (53 out of 1640, 3.2%). There was an increased risk of non-serious adverse events (AEs) with cannabinoids compared with placebo. Overall, the authors found that cannabinoids are an effective form of pain control in this patient population, with a particularly strong effect among those cannabinoids that are orally administered. However, these studies were found to be limited by overall quality, which were largely underpowered, selective, and inconsistent in their reporting. This preliminary evidence of effectiveness indicates the need for high-quality RCTs in orthopedic areas. The FDA has not approved a cannabinoid medication to treat cLBP. Here the investigators propose to study the effects of THC for several reasons. First, although both smoked cannabis and THC decrease pain sensitivity, increase pain tolerance, and decrease subjective ratings of pain intensity, THC produces more consistent analgesia for a longer duration. Second, the therapeutic effects of cannabinoids are best established for THC. Third, defined substances, such as purified cannabinoid compounds, are preferable to plant products, which are of variable and uncertain composition. Use of defined cannabinoids permits a more precise evaluation of their effects, whether combined or alone. Finally, compared with marijuana, THC produces lower ratings of abuse-related subjective effects, which can be predictive of use and abuse patterns. Hence, the investigators have elected to study THC. The primary objective of this double-blind, randomized, placebo-controlled, 1-site study is to explore the safety and tolerability of THC, versus placebo when orally administered to patients suffering from chronic pain.
Open study record