Systematically Testing the Evidence on Marijuana

2.1. General To evaluate the efficacy and safety of a Cannabis sativa extract (CBD (Cannabidiol) + up to 0.3% THC (Delta-9-tetrahydrocannabinol)), compared to placebo, in the treatment of cocaine/crack use disorder. 2.2. Specifics Compare the amount and frequency of cocaine use between the group treated with Cannabis sativa extract and the placebo group Compare adherence to treatment between the group treated with Cannabis sativa extract and the placebo group Evaluate the prevalence and intensity of depressive and anxious symptoms in patients using Cannabis sativa extract compared to patients using placebo Evaluate the incidence and severity of side effects in the active group compared to placebo.

First Posted: December 6, 2023

Condition(s): Cocaine Dependence

Intervention(s): Cannabis Extract Oil SR Capsule

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: University of Sao Paulo General Hospital

Principal Investigator: André Malbergier, MD, MPH, Phd

Completion Date (primary or actual): October 23, 2024

CT.gov Identifier: NCT06159387

A phase I, single center crossover study. The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers. The main question it aims to answer is: •If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose). The secondary is: •If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil. Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.

First Posted: November 29, 2023

Condition(s): Cannabis

Intervention(s): THC/CBD S.E powder, THC/CBD oil

Status: Recruiting

Enrollment (expected or actual): 14

Allocation: Non-Randomized

Sponsor: CapSoil

Principal Investigator:

Completion Date (primary or actual): February 1, 2024

CT.gov Identifier: NCT06149988

The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.

First Posted: November 18, 2023

Condition(s): Obesity

Intervention(s): Cannabis, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of Kentucky

Principal Investigator: Joshua A. Lile, Ph.D., Professor

Completion Date (primary or actual): January 2026

CT.gov Identifier: NCT06137365

Cannabidiol oil has been shown to be effective in treating chemotherapy induced nausea and vomiting, but there is limited information on its usefulness in nausea and vomiting that can occur after surgery. The goal of this study is to determine the effect of Cannabidiol oil on the frequency of nausea and vomiting in the first 24 hours after a gynaecological procedure. Other effects that will be assessed will include: The effect of Cannabidiol oil on the level of pain and amount of pain medications needed in the first 24 hours after a gynaecological operation. The effect of Cannabidiol oil on patients' overall satisfaction with the anaesthetic experience. Some participants will be administered Cannabidiol oil under the tongue two to three hours before their procedure and an equal number will receive a placebo oil, similar in taste. This will be done randomly to minimise introducing bias. We will then compare both groups in the postoperative period to see if the Cannabidiol oil made any difference.

First Posted: November 18, 2023

Condition(s): Postoperative Nausea and Vomiting

Intervention(s): Cannabidiol Oil, Placebo

Status: Recruiting

Enrollment (expected or actual): 120

Allocation: Randomized

Sponsor: The University of The West Indies

Principal Investigator:

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

CT.gov Identifier: NCT06137027

The investigators will randomly assign participants with social anxiety disorder to receive oral cannabidiol (CBD) or placebo. Participants will undergo a fear conditioning and extinction trial, and the investigators will examine whether CBD increases the degree of fear reduction during extinction.

First Posted: November 9, 2023

Condition(s): Social Anxiety Disorder

Intervention(s): Fear extinction, Cannabidiol Cap/Tab, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Hartford Hospital

Principal Investigator:

Completion Date (primary or actual): September 30, 2024

CT.gov Identifier: NCT06123702

The goal of this study is to understand the changes in neural correlates of reward in adolescents with and without Cannabis Use Disorder (CUD). The study will collect functional magnetic resonance imaging (fMRI) data at 3 different timepoints with the primary goals of understanding striatal reward-based activation during a Monetary Incentive Delay Task and fronto-striatal fMRI resting-state functional connectivity. The study will also explore self-reported impulsivity. The long-term goal is to advance scientific understanding of neural changes associated with cannabis abstinence and inter-individual variability that cannot be otherwise measured in preexisting observational cohorts such as the Adolescent Brain Cognitive Development Study. This parallel intervention study will collect fMRI data in adolescents ages 15-18 years old with and without CUD at three different timepoints over the course of their intervention. Utilizing a validated paradigm, adolescents with CUD will be randomized to 6-weeks of either incentivized, biochemically verified abstinence via contingency management or monitoring with no required abstinence. Age- and sex-matched adolescents with no lifetime history of cannabis use will also complete the protocol. Participants will complete 8 study visits (3 with fMRI scans) involving urinalysis to confirm cannabis self-report and measures of impulsivity.

First Posted: November 9, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): CB-Abst, CB-Mon

Status: Not yet recruiting

Enrollment (expected or actual): 64

Allocation: N/A

Sponsor: University of Minnesota

Principal Investigator:

Completion Date (primary or actual): January 15, 2028

CT.gov Identifier: NCT06124846

Though regulated cannabis sales are increasing, little is known about the individual health effects of cannabis regulation. Data from countries with a regulated market can be used to test the effect of regulation on the price of cannabis in the illicit market, and to explore its effect on social and health outcomes at the societal level, but strength of evidence for individual health and social outcomes is more limited because it must be aggregated on a state or country level. Data on individual and social outcomes should include baseline measurements before and outcome measurements after regulations changed. In this context, randomized-controlled trials are the least biased source of data on the effects of interventions. The SCRIPT study aims to investigate the individual health and social impact on recreational cannabis users who are allowed to purchase authorized, regulated cannabis from Swiss pharmacies compared to users who buy cannabis on the illicit market. Participants are randomly allocated in one of the two groups and followed-up for 6 months. After 6 months, all participants are allowed to participate in the intervention and the cohort is followed up for another 18 months. The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles. The SCRIPT study adheres to rigorous quality criteria for the production and storage of regulated cannabis products. Only vaping / vaporizing electronic devices which are validated to reduce exposure to toxicants compared to cannabis smoking are recommended.

First Posted: November 7, 2023

Condition(s): Marijuana Smoking, Cannabis, Cannabis Use

Intervention(s): Regulated cannabis from authorized pharmacies, Cannabis from the illicit market

Status: Recruiting

Enrollment (expected or actual): 1091

Allocation: Randomized

Sponsor: University of Bern

Principal Investigator:

Completion Date (primary or actual): November 2025

CT.gov Identifier: NCT06120855

The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.

First Posted: November 2, 2023

Condition(s): Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy

Intervention(s): Epidiolex

Status: Not yet recruiting

Enrollment (expected or actual): 50

Allocation:

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): August 31, 2033

CT.gov Identifier: NCT06113237

There is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation (dTMS) stimulation as a treatment for cannabis use disorder (CUD), but no studies to date have examined this. Evidence of benefit could expand the treatment options available for CUD but require randomized controlled trials (RCTs) to evaluate its efficacy. Toward an RCT of this intervention, the proposed study is a phase 1 open-label pilot trial of dTMS for adults with CUD. This study will establish the viability of an H4 protocol constituting an active arm of a future double-blind RCT.

First Posted: November 2, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): dTMS stimulation via the H4 coil

Status: Not yet recruiting

Enrollment (expected or actual): 10

Allocation: N/A

Sponsor: St. Joseph's Healthcare Hamilton

Principal Investigator: James MacKillop, Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT06114212

The Purpose of this study is to assess the safety and efficacy of Cannabidiol on treatment of Carpal Tunnel Syndrome.

First Posted: October 31, 2023

Condition(s): Carpal Tunnel Syndrome

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: University of Virginia

Principal Investigator: Brent DeGeorge, Plastic Surgeon and Assistant Professor

Completion Date (primary or actual): December 1, 2024

CT.gov Identifier: NCT06108349

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

First Posted: October 30, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 165

Allocation: Randomized

Sponsor: University of Colorado, Boulder

Principal Investigator: L. Cinnamon Bidwell, PI

Completion Date (primary or actual): March 31, 2028

CT.gov Identifier: NCT06107062

The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20) and 2) to determine if different doses of CBD modulate other THC induced behavioral effects, compared with the control product and 3)To explore qualitatively whether CBD modulates THC effects by mechanisms that are not detected with standard clinical research tools.

First Posted: October 25, 2023

Condition(s): Cannabis, THC

Intervention(s): ∆9-tetrahydrocannabinol

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

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

Principal Investigator:

Completion Date (primary or actual): July 31, 2025

CT.gov Identifier: NCT06099379

The main objectives of this study were to test if 2 different doses of Cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.

First Posted: October 27, 2023

Condition(s): Alcohol Use Disorder

Intervention(s): 200mg Cannabidiol oral solution, 30mg Cannabidiol oral solution, Placebo

Status: Completed

Enrollment (expected or actual): 36

Allocation: Randomized

Sponsor: Colorado State University

Principal Investigator:

Completion Date (primary or actual): March 3, 2022

CT.gov Identifier: NCT06105138

The aim of this study is to compare the effectiveness of combined treatment with paravertebral oxygen-ozone injections and topical patches containing Cannabidiol and β-Caryophyllene in patients with neck pain by evaluating the following aspects: Reduction of pain Reduction of disability associated with neck pain

First Posted: October 25, 2023

Condition(s): Neck Pain

Intervention(s): Cannabidiol and β-Caryophyllene Patch, Oxygen-Ozone Therapy

Status: Not yet recruiting

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Humanitas Clinical and Research Center

Principal Investigator: Cristiano Sconza, Principal Investigator

Completion Date (primary or actual): September 1, 2024

CT.gov Identifier: NCT06099171

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance , which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed project aims to optimize an existing two-session computerized distress tolerance intervention and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session, its active ingredient bolstered, and augmented with smart phone-delivered therapy reminders. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. Distress intolerance, cannabis use, and psychosocial functioning outcomes will be evaluated. As an exploratory aim, a wristworn device will be used to measure objective stress responding in the real-world during the intervention period. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning.

First Posted: October 16, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Emotional Engagement Distress Tolerance Intervention, Health Education Intervention

Status: Not yet recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Auburn University

Principal Investigator: Richard Macatee, Assistant Professor

Completion Date (primary or actual): April 1, 2026

CT.gov Identifier: NCT06085222

The endocannabinoid system (ECS) is a complex endogenous signaling system made up of transmembrane cannabinoid receptors (CB1 and CB2 receptors), their endogenous lipid-derived ligands (the endocannabinoids - eCBs), and enzymes for ligand biosynthesis and degradation. Interestingly, exercise increase plasma AEA, one of the most famous endocannabinoid. This increase could be involved in exercise-induced neurogenesis and other beneficial exercise adaptations. Chronic cannabis use is associated with alteration of ECS activity. The aim of the study is to compare ECS response to exercise between chronic cannabis users and non-users.

First Posted: October 13, 2023

Condition(s): Cannabis User

Intervention(s): activity test

Status: Not yet recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: University Hospital, Lille

Principal Investigator:

Completion Date (primary or actual): December 2025

CT.gov Identifier: NCT06081218

The goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25. The main question it aims to answer is: will cannabis users who switch to less potent THC products demonstrate improved cognitive function compared to baseline? Other questions this study aims to answer include: Can researchers accurately assess THC consumption among frequent cannabis users? Can researchers effectively incentivize cannabis users to use less potent THC products? Do genetic variations in THC metabolism impact urinary THC excretion? Do genetic variations in THC metabolism impact cognitive performance in cannabis users? Are quantitative urinary THC values predictive of cognitive impairment? How can researchers use research findings to inform harm reduction practices for people who use cannabis? Participants will submit blood and urine samples and be incentivized to use less potent THC products.

First Posted: October 11, 2023

Condition(s): Cannabis Use, THC, Marijuana Use, Cognitive Impairment, THC Vaping

Intervention(s): 15% THC Potency Reduction, 35% THC Potency Reduction

Status: Not yet recruiting

Enrollment (expected or actual): 110

Allocation: Randomized

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): June 30, 2024

CT.gov Identifier: NCT06077292

The main objectives of this study were to test if a singular dose of Cannabidiol (1) enhances the learning and memory of healthy human subjects, (2) test if Cannabidiol has negative effects on Retroactive and Proactive Interference during learning, (3) and test if demographic factors will influence CBD's modulation of human learning and memory.

First Posted: October 10, 2023

Condition(s): Memory

Intervention(s): Cannabidiol in Oral Dose Form, Placebo in Oral Dose Form

Status: Completed

Enrollment (expected or actual): 57

Allocation: Randomized

Sponsor: Colorado State University

Principal Investigator:

Completion Date (primary or actual): November 6, 2020

CT.gov Identifier: NCT06074172

Over 46 million US adults report use of cannabidiol (CBD), primarily to treat medical ailments. The growing CBD market spans the range of products that the US Food and Drug Administration (FDA) regulates including drugs, dietary supplements, food/beverages and cosmetics. CBD cannot be marketed as having therapeutic benefits (without FDA's approval), be false or misleading to consumers, or convey the products are approved or endorsed by the FDA. In addition, CBD cannot be marketed as a food additive or dietary supplement since it is an active ingredient in an approved drug, Epidiolex. Despite this, CBD products have been illicitly advertised to consumers with these claims including unsubstantiated health claims that promote benefits including curing cancer and preventing Alzheimer's disease. These types of claims may reduce perceptions of harm and increase perceived benefits of use. This study aims to evaluate how consumers perceive real-world CBD advertisements. To that end, we will implement an online survey and randomize adult participants (ages 18-65) to see various advertisements made about CBD to determine if they interpret advertisements as making health claims that are currently prohibited by the FDA.

First Posted: October 6, 2023

Condition(s): Perceptions

Intervention(s): CBD advertisements

Status: Completed

Enrollment (expected or actual): 3076

Allocation: N/A

Sponsor: Wake Forest University Health Sciences

Principal Investigator:

Completion Date (primary or actual): November 20, 2023

CT.gov Identifier: NCT06069713

In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.

First Posted: September 29, 2023

Condition(s): Cannabis Smoking, Driving Impaired

Intervention(s): Active smoked cannabis, Placebo smoked cannabis

Status: Recruiting

Enrollment (expected or actual): 300

Allocation: Randomized

Sponsor: Bayliss J. Camp, PhD

Principal Investigator: Bayliss J. Camp, PhD, Chief, Research & Development Branch

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

CT.gov Identifier: NCT06059677

Cannabis is widely used worldwide and is associated with negative outcomes including cannabis use disorder (CanUD), psychosis, and cognitive impairment amongst others. Given the legalization of "recreational" and "medical" cannabis globally, the increasing availability of cannabis, the higher potency of cannabis, the availability of highly potent cannabinoid products, the commercialization of cannabis, and the rising rates of cannabis use, it is critical to understand how genetic factors influence 1) an individual's vulnerability for addiction and psychosis, 2) the response to cannabinoids, 3) the response to novel treatments for CanUD. CanUD is strongly genetically influenced; the investigators published the first CanUD genomewide association study (GWAS) with genomewide-significant results; however, the precise nature of the contribution of genetic factors in the development of CanUD is still not clear. Cannabis exposure has also been linked to a number of psychosis outcomes including schizophrenia (SCZ). SCZ is highly heritable and population-based and genetics studies both support a bidirectional genetic relationship between SCZ and CanUD. However, the precise contribution of genetic factors in the development of psychosis outcomes related to cannabis are not clear.

First Posted: September 28, 2023

Condition(s): Schizophrenia, Cannabis Use Disorder

Intervention(s): Delta-9-THC, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 215

Allocation: Randomized

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Albert E. Kent Endowed Professor of Psychiatry

Completion Date (primary or actual): December 31, 2028

CT.gov Identifier: NCT06058702

This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.

First Posted: September 26, 2023

Condition(s): Health Services for the Aged

Intervention(s): Cannabis (up to three doses)

Status: Not yet recruiting

Enrollment (expected or actual): 5

Allocation: N/A

Sponsor: University of Arkansas

Principal Investigator:

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT06055309

We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety

First Posted: September 26, 2023

Condition(s): Cigarette Smoking-Related Carcinoma

Intervention(s): Vape device, Joint, Marijuana via vape device, Marijuana via joint

Status: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Roswell Park Cancer Institute

Principal Investigator:

Completion Date (primary or actual): January 15, 2026

CT.gov Identifier: NCT06055231

The use of non-medical cannabidiol (CBD) has been growing recently in France and in the world, in young but also older adults. Few data are available on the use of cannabidiol in older adults. A better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the CBD uptake in this population and avoid potential adverse events.

First Posted: October 23, 2023

Condition(s): Aging, Frailty

Intervention(s): questionnaire

Status: Recruiting

Enrollment (expected or actual): 140

Allocation:

Sponsor: University Hospital, Toulouse

Principal Investigator:

Completion Date (primary or actual): December 26, 2023

CT.gov Identifier: NCT06094582

The goal of the observational study is to learn how black and white patients with solid tumor cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological assessment through a smart phone app and surveys to assess patient-reported pain and other symptoms as to inform clinical practice and guidelines for underrepresented populations.

First Posted: September 14, 2023

Condition(s): Cancer

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 600

Allocation:

Sponsor: State University of New York at Buffalo

Principal Investigator: Rebecca Ashare, Co- Principal Investigator

Completion Date (primary or actual): September 30, 2026

CT.gov Identifier: NCT06037681