Systematically Testing the Evidence on Marijuana

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 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

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: Recruiting

Enrollment (expected or actual): 24

Allocation: Non-Randomized

Sponsor: Hurd,Yasmin, Ph.D.

Principal Investigator:

Completion Date (primary or actual): August 30, 2022

CT.gov Identifier: NCT05023070

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 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): July 2023

CT.gov Identifier: NCT05226351

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: Not yet recruiting

Enrollment (expected or actual): 303

Allocation: Randomized

Sponsor: York University

Principal Investigator: Matthew Keough, Assistant Professor

Completion Date (primary or actual): March 2023

CT.gov Identifier: NCT04965012

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

The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001 during a THC challenge. Results of this study will inform the future potential use of ANEB-001 as an emergency treatment for THC intoxication.

First Posted: March 16, 2022

Condition(s): Acute Cannabinoid Intoxication

Intervention(s): ANEB-001, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Anebulo Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): December 31, 2022

CT.gov Identifier: NCT05282797

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: Recruiting

Enrollment (expected or actual): 120

Allocation: Randomized

Sponsor: Oregon Research Institute

Principal Investigator:

Completion Date (primary or actual): May 31, 2022

CT.gov Identifier: NCT04923230

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: Active, not recruiting

Enrollment (expected or actual): 25

Allocation: Randomized

Sponsor: Colorado State University

Principal Investigator: Christopher Bell, Associate Professor

Completion Date (primary or actual): May 10, 2022

CT.gov Identifier: NCT04971837

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, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: Yale University

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

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

CT.gov Identifier: NCT04920539

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: Recruiting

Enrollment (expected or actual): 1000

Allocation:

Sponsor: Empower Research Inc

Principal Investigator:

Completion Date (primary or actual): December 30, 2021

CT.gov Identifier: NCT04965740

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

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: Enrolling by invitation

Enrollment (expected or actual): 15

Allocation: N/A

Sponsor: University of South Florida

Principal Investigator: Selim Benbadis, MD, Professor of Neurology

Completion Date (primary or actual): October 5, 2021

CT.gov Identifier: NCT04899050

Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol [THC], cannabidiol [CBD]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.

First Posted: May 12, 2021

Condition(s): HIV-1-infection

Intervention(s): 10 mg Δ9-tetrahydrocannabinol (THC), 600 mg cannabidiol (CBD), Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 138

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Arpi Minassian, Clinical Professor of Psychiatry

Completion Date (primary or actual): January 31, 2026

CT.gov Identifier: NCT04883255

This is a seamless Phase 2/3, double-blind, randomized, placebo-controlled clinical study in patients diagnosed with PWS. Following consent (or legal guardian consent and patient assent as appropriate), patients will be screened for eligibility to participate in this study.

First Posted: October 28, 2021

Condition(s): Prader-Willi Syndrome

Intervention(s): RAD011, Placebo

Status: Recruiting

Enrollment (expected or actual): 220

Allocation: Randomized

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

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

CT.gov Identifier: NCT05098509

Chronic inflammation, which is defined as a persistent, low-grade inflammatory response within the body, is associated with many of the negative health conditions which are prevalent in our society today. It is most well-known for its role in the progression of diseases including obesity, metabolic syndrome, cancer, cardiovascular disease, and diabetes. Chronic inflammation is also linked to many of the underlying factors associated with disease development including perturbations in sleep, and mental health status such as depression, anxiety, fatigue, and quality of life. Natural killer cells, commonly referred to as NK cells, are a subset of white blood cells that play an important role in the coordination of inflammation in the body. Although many interventions aimed at controlling chronic inflammation and enhancing NK cell number and activity have been explored, relatively few have been administered without significant barriers. Cannabidiol (CBD), a non-psychoactive hemp derivative, is a potential, attractive therapeutic target. However, there is very little information in humans that addresses the potential of CBD to improve your health and immune function. The overall goal of this study is to explore the effects of 8-weeks of CBD supplementation on mental and physical health, sleep measures, and NK cell number and cytotoxic function. Specific Aim 1. Explore the effect of 8-weeks of CBD administration on sleep measures as well as measures of mental and physical health in conjunction with measurements of NK cell number and function.

First Posted: May 11, 2021

Condition(s): Healthy

Intervention(s): Cannabidiol (CBD)

Status: Completed

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

Completion Date (primary or actual): March 18, 2022

CT.gov Identifier: NCT04881539

No studies of cannabidiol (CBD) have focused on Anorexia Nervosa (AN). Dose, side effects, tolerability, acceptability of pure CBD in AN must be established. The current study is an important first step in the investigation of CBD for AN. Cannabis products have been recently legalized in many states, and CBD in particular has been shown to reduce anxiety. Therefore, CBD may represent a promising new treatment for AN. The endocannabinoid system is involved in the regulation of functions relevant to eating disorders. Furthermore, data suggest that eating disorders are associated with alterations of the endocannabinoid system. Prior attempts to target the endocannabinoid system in AN have focused on CB1 receptor agonists that can increase anxiety. Moreover, CBD may be particularly beneficial in decreasing anxiety in AN via its action at serotonin receptors. Lastly, the impact of CBD on eating behavior and weight in AN must be determined. The current study seeks to explore these hypotheses using the aims in the following section.

First Posted: May 7, 2021

Condition(s): Anorexia Nervosa

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Guido Frank, Professor

Completion Date (primary or actual): May 2023

CT.gov Identifier: NCT04878627

The aim of the current project is to investigate the impact of an activation of the cannabinoid system with an exogenous cannabinoid dronabinol (delta-9-tetrahydrocannabinol) on the formation of intrusive memories after analog trauma. A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of exogenous dronabinol on intrusive symptoms during exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral dronabinol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls. This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.

First Posted: May 4, 2021

Condition(s): Intrusive Memories

Intervention(s): Dronabinol, Placebo

Status: Recruiting

Enrollment (expected or actual): 291

Allocation: Randomized

Sponsor: Charite University, Berlin, Germany

Principal Investigator: Stefan Roepke, Prof. Dr.

Completion Date (primary or actual): December 31, 2022

CT.gov Identifier: NCT04871269

Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

First Posted: May 4, 2021

Condition(s): Schizophrenia, Cannabis-Induced Disorder

Intervention(s): Transcranial direct current stimulation (tDCS) active, Transcranial direct current stimulation (tDCS) non active

Status: Not yet recruiting

Enrollment (expected or actual): 110

Allocation: Randomized

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Principal Investigator:

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

CT.gov Identifier: NCT04871048

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

First Posted: May 5, 2021

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 45

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

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

CT.gov Identifier: NCT04873453

The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.

First Posted: April 29, 2021

Condition(s): Marijuana, HIV Infections

Intervention(s): Contingency Management - Cannabis

Status: Recruiting

Enrollment (expected or actual): 45

Allocation: N/A

Sponsor: Baylor University

Principal Investigator: Emeka Okafor, Assistant Professor

Completion Date (primary or actual): July 1, 2022

CT.gov Identifier: NCT04866004