Systematically Testing the Evidence on Marijuana

This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.

First Posted: August 9, 2021

Condition(s): Long COVID

Intervention(s): MediCabilis Cannabis sativa 50

Status: Completed

Enrollment (expected or actual): 12

Allocation: N/A

Sponsor: Bod Australia

Principal Investigator:

Completion Date (primary or actual): January 6, 2023

CT.gov Identifier: NCT04997395

This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).

First Posted: August 5, 2021

Condition(s): Osteoarthritis, Knee, Osteoarthritis of the Knee

Intervention(s): Placebo, Cannabidiol (CBD), Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: Steven E Harte, PhD

Principal Investigator: Steven E Harte, PhD, Associate Professor of Anesthesiology and Internal Medicine Associate Director, Chronic Pain and Fatigue Research Center

Completion Date (primary or actual): June 30, 2025

CT.gov Identifier: NCT04992624

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment or that changed the preventive treatment less than 3 months from the study start, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus. Patients on vitamin K anticoagulant medicines, as warfarin. Randomization using a computacional system will stratify participants in each group by gender (F/M), age (25-34/35-44/45-54/55-65yo), headache days presented in the baseline month (5-10/11-15/16-20/21-25/26-30), overuse medication (yes or no). After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum daily dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. Clinical data will be registered on a personalized headache diary developed to this study using MyCap, from RedCap System, as an APP for daily entries using smartphones, androids or IOS system. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary endpoints, the proposal of which is to publish the data regardless of the results obtained.

First Posted: August 4, 2021

Condition(s): Chronic Migraine, Headache, Overuse Headache Medication

Intervention(s): Placebo oral drops, Cannabidiol + Cannabigerol + Tetrahydrocannabinol 133/66/4mg

Status: Recruiting

Enrollment (expected or actual): 110

Allocation: Randomized

Sponsor: Hospital Israelita Albert Einstein

Principal Investigator: Alexandre Kaup, Principal Investigator, MD

Completion Date (primary or actual): October 18, 2023

CT.gov Identifier: NCT04989413

The study examined a community based cannabis cessation program in Norway (CCP). The CCP uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising ~15 individual sessions. From 2005 onwards, the CCP was implemented as a low-threshold community-based program in several Norwegian municipalities, e.g., Kristiansand, Fredrikstad and Oslo. The study had an observational one-group pre- / post test design. Outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (SoC) measured post-intervention (T2) and at a 3 months follow-up (T3).

First Posted: August 4, 2021

Condition(s): Cannabis Use

Intervention(s): Cannabis cessation Program

Status: Completed

Enrollment (expected or actual): 102

Allocation:

Sponsor: Sorlandet Hospital HF

Principal Investigator:

Completion Date (primary or actual): January 31, 2017

CT.gov Identifier: NCT04989205

The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions. However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.

First Posted: July 29, 2021

Condition(s): Pain, Acute

Intervention(s): Active Cannabis, Placebo Cannabis

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Fadel Zeidan, Associate Professor of Anesthesiology

Completion Date (primary or actual): December 15, 2024

CT.gov Identifier: NCT04982965

The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.

First Posted: July 27, 2021

Condition(s): Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome, Hoarding Disorder

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 15

Allocation: N/A

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): September 2023

CT.gov Identifier: NCT04978428

This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.

First Posted: July 26, 2021

Condition(s): Chronic Pain, Neck Pain, Back Pain, Pain, Pain, Chronic, Pain, Back, Pain, Neck, CBD, THC

Intervention(s): Cybis™ 10:25 THC:CBD oil

Status: Completed

Enrollment (expected or actual): 28

Allocation: N/A

Sponsor: Cymra Life Sciences

Principal Investigator:

Completion Date (primary or actual): June 15, 2022

CT.gov Identifier: NCT04976738

The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.

First Posted: July 29, 2021

Condition(s): Opioid-use Disorder

Intervention(s): Cannabidiol 100 MG/ML [Epidiolex], Placebo

Status: Completed

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: Brigham and Women's Hospital

Principal Investigator: Joji Suzuki, MD, Director, Division of Addiction Psychiatry

Completion Date (primary or actual): December 2, 2022

CT.gov Identifier: NCT04982029

The cannabinoid has benefits in many aspects but the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and critical cytokine level in SSc compared with placebo in SSc patients and the adverse events associated with cannabinoids in those patients.

First Posted: June 13, 2022

Condition(s): Systemic Sclerosis, Malnutrition, Loss of Appetite

Intervention(s): CBD oil, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Khon Kaen University

Principal Investigator: Chingching Foocharoen, Professor

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT05416697

Osteoarthritis (OA), the most common form of arthritis, is a leading cause of disability, affecting the quality of life, pain, and physical functioning of 4.6 million Canadians. About half of OA patients have limited response to primary therapy. The number of OA patients continues to rise, affecting the quality of life of those with OA. There is a dire need to develop future effective treatment options. Cannabis is a potential therapy for those with OA and may provide analgesic, anti-inflammatory, and disease modifying effects. The common barriers to use are a lack of knowledge regarding efficacy, access, and commonly used products, doses and routes of administration. No high-quality clinical trials of cannabis for OA have been conducted, leaving physicians struggling to guide and inform patients regarding symptom relief. Findings from clinical trials of cannabis for other painful conditions have been variable, perhaps due to suboptimal cannabis products and failure to consider important patient characteristics. The goal of the current study is to characterize patient- and cannabis-level factors that are associated with OA pain and address other knowledge gaps.

First Posted: July 21, 2021

Condition(s): Osteo Arthritis Knee

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 1200

Allocation:

Sponsor: University Health Network, Toronto

Principal Investigator: Hance Clarke, Director Pain Services, Toronto General Hospital

Completion Date (primary or actual): December 31, 2024

CT.gov Identifier: NCT04971629

Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.

First Posted: July 20, 2021

Condition(s): Psychotic Disorder, Marijuana Use, Young Adult

Intervention(s): CHAMPS

Status: Enrolling by invitation

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

Completion Date (primary or actual): September 30, 2023

CT.gov Identifier: NCT04968275

Cannabis is a frequently-used psychoactive substance. While the majority of individuals can use cannabis without experiencing problems, a small minority of people develop cannabis problems. Despite the small-to-medium reported effect sizes of cognitive behavioural therapy (CBT) and motivational enhancement therapy (MET) treatments for cannabis misuse, many cannabis users do not seek treatment. Online CBT/MET programs have the potential to be cost-effective and accessible, and offer a less stigmatizing option for treatment. These programs may also help capture cannabis users who experience subclinical problems, who are not captured by traditional treatment. Existing treatment programs also need to be adapted to maximize participant retention and increase treatment completion, as many current cannabis use treatment programs have significant drop-out rates. Hence, the goal of the proposed randomized controlled trial (RCT) is to examine the efficacy of an online evidence-based CBT/MET treatment program. Outcomes of a combined CBT/MET treatment program will be compared to a CBT-only treatment program and a waitlist control. This research will provide insight into the novel contribution of MET to online CBT treatment programs for cannabis misuse. The researchers are hoping to recruit 303 participants for this study from Central and Eastern Canada. Participants will be randomly assigned to one of the treatment groups (i.e., CBT with MET, CBT without MET) or the psychoeducational control group. Individuals in either treatment group will be given 6 weeks to work through 8 online modules. Throughout the modules, participants will identify goals related to cannabis use, learn strategies to cope with cannabis cravings, triggers, and social pressures and learn to prevent relapse. Participants randomly assigned to the control (i.e., psychoeducation) will receive links to websites that provide general psychoeducation about cannabis use and wellbeing. All participants will complete online assessment measures at baseline, end of treatment, and at follow up approximately one month later (i.e., 0 weeks, 6 weeks, 10 weeks) in order to assess the efficacy of the treatment. At the end of the study, individuals in the control group will be given access to the CBT without MET treatment.

First Posted: July 16, 2021

Condition(s): Marijuana Use, Marijuana Dependence

Intervention(s): Online CBT with MET treatment, CBT without MET treatment

Status: Completed

Enrollment (expected or actual): 152

Allocation: Randomized

Sponsor: York University

Principal Investigator: Matthew Keough, Assistant Professor

Completion Date (primary or actual): October 1, 2023

CT.gov Identifier: NCT04965012

The goal of the current study is to evaluate the bioavaibiltiy of CBD in normal healthy Individuals. This is an open cross-over design study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

First Posted: August 26, 2021

Condition(s): Healthy

Intervention(s): Cannabidiol, Cannabidiol, Cannabidiol, Cannabidiol

Status: Active, not recruiting

Enrollment (expected or actual): 24

Allocation: Non-Randomized

Sponsor: Hurd,Yasmin, Ph.D.

Principal Investigator:

Completion Date (primary or actual): February 14, 2023

CT.gov Identifier: NCT05023070

Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.

First Posted: July 12, 2021

Condition(s): Healthy Volunteers

Intervention(s): SP-104, Naltrexone immediate release oral capsules

Status: Completed

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Scilex Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): December 20, 2021

CT.gov Identifier: NCT04958876

Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / <0.025% CBD) or placebo (0% THC / 0% CBD). The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.

First Posted: July 21, 2021

Condition(s): Driving Behavior, Driving Under the Influence

Intervention(s): Placebo (Lactose) Capsule, 0.75 mg Alprazolam Capsule, Cannabis (6.18% THC / <0.025% CBD), Cannabis (0%/ THC / 0% CBD)

Status: Completed

Enrollment (expected or actual): 13

Allocation: Randomized

Sponsor: Timothy L. Brown

Principal Investigator: Timothy L. Brown, Director of Drugged Driving Research

Completion Date (primary or actual): August 21, 2021

CT.gov Identifier: NCT04970342

A cross-sectional and retrospective chart review study was conducted at the Princess Mother National Institute on Drug Abuse Treatment (PMNIDAT), Thailand. All patients who admitted at PMNIDAT from October 2013 to September 2019 were included. Patients aged 18-65 years who met the International Classification of Disease-10 (ICD-10) criteria of CIP and Had a positive urine test of cannabis were included. Cannabis use is a component cause of psychosis.More than half of symptoms of cannabis-induced psychosis (CIP) were hallucination, delusion, irritable and anxiety. Antipsychotic drug was still a key psychotropic drugs for treatment of CIP. However, antidepressants and benzodiazepines were commonly used for treatment of other symptoms beyond psychotics

First Posted: June 30, 2021

Condition(s): Cannabis

Intervention(s): cannabis

Status: Completed

Enrollment (expected or actual): 317

Allocation:

Sponsor: Mahidol University

Principal Investigator:

Completion Date (primary or actual): May 31, 2020

CT.gov Identifier: NCT04945031

Recent data suggest that the cannabinoid-system is involved in stress regulation and posttraumatic stress disorder (PTSD). Low endocannabinoid signaling has been found in PTSD patients and might even present a precondition to develop PTSD after trauma. The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid (dronabinol, i.e., delta-9-tetrahydrocannabinol) on fear conditioning.

First Posted: February 7, 2022

Condition(s): Post Traumatic Stress Disorder

Intervention(s): Dronabinol 2.5 mg, Placebo

Status: Recruiting

Enrollment (expected or actual): 180

Allocation: Randomized

Sponsor: Charite University, Berlin, Germany

Principal Investigator: Stefan Roepke, Prof. Dr. Stefan Röpke

Completion Date (primary or actual): October 2023

CT.gov Identifier: NCT05226351

The prevalence of major depressive disorder (MDD) is ~5.0%, and rates of co-occurring SUDs in these patients approach 40-50%. Specifically, rates of co-morbid cannabis use disorder (CUD) in patients with MDD are elevated 2-3 fold compared to 2.9% in the general population, and is associated with poorer treatment outcomes and impaired cognitive and psychosocial functioning in comparison to MDD patients without CUD. Most studies of cannabis use in MDD are cross-sectional in design, and therefore causal relationships are unclear. This study investigates the effects of cannabis abstinence over a 28-day period in patients with MDD with co-occurring CUD using a randomized controlled design, namely contingent reinforcement.

First Posted: June 23, 2021

Condition(s): Cannabis Use, Major Depressive Disorder, Cognitive Impairment

Intervention(s): Contingency Reinforcement, Non-Contingency Reinforcement

Status: Recruiting

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): April 30, 2025

CT.gov Identifier: NCT04935619

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

First Posted: June 18, 2021

Condition(s): Cannabis Intoxication, Alcohol Intoxication

Intervention(s): Cannabis, Alcohol

Status: Recruiting

Enrollment (expected or actual): 90

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): May 1, 2025

CT.gov Identifier: NCT04931095

The randomized clinical trial involves the pilot-testing of a theory-guided, empirically based, and low-cost intervention designed for legal medical marijuana-using parents to enhance parenting behaviors that limit youth exposure to marijuana, reduce or halt youth marijuana use, and increase youth awareness of the harmful consequences of marijuana during the youth years. Parents will be randomized to an intervention condition or to a wait list control condition. Pre- and post-intervention assessments will evaluate parent and youth marijuana and other substance use, perceptions and attitudes about marijuana, parenting and family functioning, and youth behavioral health.

First Posted: June 11, 2021

Condition(s): Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate

Intervention(s): Cannabis Actions and Practices Resource for Parents

Status: Completed

Enrollment (expected or actual): 120

Allocation: Randomized

Sponsor: Oregon Research Institute

Principal Investigator:

Completion Date (primary or actual): May 31, 2023

CT.gov Identifier: NCT04923230

In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterations differ between HIV-infected and HIV-uninfected host genomes.

First Posted: June 10, 2021

Condition(s): HIV Infections, Healthy

Intervention(s): Active Delta-9-THC

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: N/A

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): June 30, 2025

CT.gov Identifier: NCT04920539

According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body. In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.

First Posted: July 22, 2021

Condition(s): Metabolism, Liver Function, Pharmacokinetics

Intervention(s): Cannabidiol (CBD) powder formulation, Cannabidiol (CBD) Oil based tincture formulation, Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation, Cannabidiol (CBD) Gum Arabic, sorbitol base formulation, Cannabidiol (CBD) Isolate in water formulation, CBD matching Placebo

Status: Completed

Enrollment (expected or actual): 26

Allocation: Randomized

Sponsor: Colorado State University

Principal Investigator: Christopher Bell, Associate Professor

Completion Date (primary or actual): December 9, 2021

CT.gov Identifier: NCT04971837

The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.

First Posted: June 2, 2021

Condition(s): Rheumatoid Arthritis, Cannabis

Intervention(s): 200mg Cannabidiol by capsules twice daily, 400mg Cannabidiol by capsules twice daily, Placebo capsules

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Veena Ranganath, MD, MS, Principal Investigator

Completion Date (primary or actual): June 10, 2024

CT.gov Identifier: NCT04911127

The primary objective of this study is to collect insights from first responders and military personnel on their need for, use of, and interest in physical and/or mental health medical marijuana or psychedelic-assisted therapy programs. These preliminary data will help to inform and guide the development of a larger patient-oriented study and the design of a clinical program geared towards enhancing therapy treatments for first responders and military personnel.

First Posted: July 16, 2021

Condition(s): PTSD, Anxiety, Anxiety Disorders, Depression, Depressive Disorder, Psychological, Psychedelic Experiences, Psychedelic Drug Dependence

Intervention(s): Cannabis

Status: Completed

Enrollment (expected or actual): 102

Allocation:

Sponsor: Empower Research Inc

Principal Investigator:

Completion Date (primary or actual): February 4, 2022

CT.gov Identifier: NCT04965740

This is a Pilot study, open-label study consisting of a screening period of up to 4 weeks, a 4-week dose-titration treatment period to dose of up to 20 mg/kg/day BID of CBD (Epidiolex), and a 30 day safety follow-up period following the last dose of study medication.

First Posted: May 24, 2021

Condition(s): Study the Efficacy of Epidiolex for Typical Absence Seizures

Intervention(s): Cannabidiol (Epidiolex)

Status: Completed

Enrollment (expected or actual): 14

Allocation: N/A

Sponsor: University of South Florida

Principal Investigator: Selim Benbadis, Professor of Neurology

Completion Date (primary or actual): May 27, 2023

CT.gov Identifier: NCT04899050