Systematically Testing the Evidence on Marijuana

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): March 30, 2025

CT.gov Identifier: NCT06055231

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

The purpose of this study is to define the mechanisms of cannabis on the genome of people with HIV who use cannabis. The investigator aims to better understand the effect of Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status dependent. This research may better inform public health policy regarding cannabis use. Depending on the results, additional studies may also build upon this research to develop more effective and specific treatments for cannabis use associated disorders.

First Posted: September 13, 2023

Condition(s): HIV

Intervention(s): Dronabinol Capsules

Status: Not yet recruiting

Enrollment (expected or actual): 160

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator:

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

CT.gov Identifier: NCT06034314

This is an unblinded pilot study of an environmental exposure to secondhand cannabis smoke in one group of healthy nonsmokers.

First Posted: September 11, 2023

Condition(s): Healthy

Intervention(s): Secondhand cannabis emissions/smoke exposure

Status: Not yet recruiting

Enrollment (expected or actual): 200

Allocation: N/A

Sponsor: University of California, San Francisco

Principal Investigator:

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

CT.gov Identifier: NCT06030674

Despite recreational cannabis now being legal in 23 states, where more than 100 million Americans reside, studies on the actual health effects are limited. This study is a randomized trial, where each participant will be instructed to consume or avoid cannabis on randomly assigned days during a 14-day monitoring period. The goal of this study is to answer the question: "Does cannabis use increase the frequency of 'early' and abnormal heart beats?" During the 14-day period, participants will wear an external heart monitor, a glucose monitor, and a fitness tracker to track heart rhythm, glucose levels, step counts, and sleep health. Participants will use a mobile app or a text messaging service for daily instructions/reminders on cannabis use, and short surveys. The investigators ask that participants smoke or vape cannabis at least once on days they are instructed to consume cannabis. Compelling evidence of heart and other health effects would be important to the clinical care of our patients.

First Posted: September 1, 2023

Condition(s): Premature Atrial Contractions, Premature Ventricular Contractions

Intervention(s): Randomized instructions

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: N/A

Sponsor: University of California, San Francisco

Principal Investigator:

Completion Date (primary or actual): November 2026

CT.gov Identifier: NCT06021613

The goal of this study is to learn about the effects of combining alcohol with cannabis concentrate products which contain high levels of THC. The main question[s] it aims to answer are, 1) How does the order in which someone consumes THC and alcohol in a given co-use session impact outcomes such as blood alcohol level, heart rate or subjective drug effects, and 2) how does THC percentage in cannabis influence outcomes following alcohol and cannabis co-administration. Participants will be scheduled for our mobile lab to come to their residence. During the session, they will: consume a standardized dose of alcohol as well as use their own preferred cannabis concentrate product. they will then remain in our mobile lab for about 4 hours and complete some surveys as well as do some cognitive tasks on an iPad every 30 minutes. They will also have their blood drawn three times throughout the session, and will periodically be asked to blood into a breathalyzer to measure blood alcohol level. Researchers will compare people who use alcohol prior to cannabis to those who use cannabis prior to alcohol to determine whether order of use impacts outcomes.

First Posted: August 21, 2023

Condition(s): Alcohol Use Disorder, Cannabis Use

Intervention(s): commercially available cannabis and commercially available alcohol

Status: Recruiting

Enrollment (expected or actual): 80

Allocation: N/A

Sponsor: Colorado State University

Principal Investigator:

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

CT.gov Identifier: NCT05999344

This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.

First Posted: August 21, 2023

Condition(s): THC, Cannabis, Cannabis Use, Cannabis Smoking, Tobacco Use, Vaping

Intervention(s): Cannabis, Nicotine, Pax Loose Leaf Vaporizer

Status: Not yet recruiting

Enrollment (expected or actual): 48

Allocation: Randomized

Sponsor: University of California, San Francisco

Principal Investigator:

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

CT.gov Identifier: NCT05999383

This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.

First Posted: August 14, 2023

Condition(s): Opioid Use Disorder, Methadone, Cannabis, Fentanyl

Intervention(s): Aurora 1:1 Drops (Indica), Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 24

Allocation: Randomized

Sponsor: BC Centre on Substance Use

Principal Investigator: M. Eugenia Socias, Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU

Completion Date (primary or actual): September 2025

CT.gov Identifier: NCT05985850

The goal of this treatment development project is to develop an adaptive ecological momentary intervention (a-EMI) for young adults using marijuana and alcohol that is grounded in self-regulation and social cognitive theories. To determine the most efficacious intervention strategies, the investigators will test variations of intervention components to identify the best combination. The study will take place at the Center for Integrated Health Care Research at Kaiser Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot testing with 6 participants, the study team will assess the feasibility and efficacy of intervention components on two primary outcomes (negative consequences and protective behavioral strategies [PBS]) using a fractional factorial experimental design, with post-intervention assessment and one- and three-month follow-ups. 136 diverse young adults recruited from KPHI who report current simultaneous alcohol and marijuana (SAM) use will be randomly assigned to one of eight groups, representing experimental conditions that include or do not include intervention strategies focused on craving reduction and PBS. As a result of this process, individual and/or combined components that lead to improved outcomes will be retained in a subsequent randomized controlled trial, while ineffective components will be eliminated.

First Posted: August 15, 2023

Condition(s): Alcohol Drinking, Cannabis Use

Intervention(s): Condition 1: Craving daily+PBS daily, Condition 2: Craving daily+PBS trigger, Condition 3: Craving trigger+PBS daily, Condition 4: Craving trigger+PBS trigger, Condition 5: PBS daily+ PBS trigger, Condition 6: Craving daily+Craving trigger, Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger, Condition 8: No daily or trigger craving or PBS

Status: Not yet recruiting

Enrollment (expected or actual): 136

Allocation: Randomized

Sponsor: Kaiser Permanente

Principal Investigator:

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

CT.gov Identifier: NCT05991882

The study is about helping teens who are involved in the court system to cut down or quit using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH, that will be used only by teens in this study. This app is a private online community where teens can work towards changing their substance use and other behavior with the help of other anonymous teens. We will use this information to learn how the app may help teens make a change and to improve the TECH app.

First Posted: August 7, 2023

Condition(s): Cannabis Use, Adolescent

Intervention(s): Treatment as usual, Teen Empowerment through Computerized Health (TECH) app

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Northwestern University

Principal Investigator: Sarah Helseth, Assistant Professor

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05979272

Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.

First Posted: August 1, 2023

Condition(s): Breast Cancer, Oral Cancer

Intervention(s): Cannabis capsules

Status: Active, not recruiting

Enrollment (expected or actual): 12

Allocation: N/A

Sponsor: Tata Memorial Hospital

Principal Investigator: Dr Rajendra A. Badwe, Doctor

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

CT.gov Identifier: NCT05969314

The goal of this observational study is to learn about the potential therapeutic effects of topical CBD products produced by Phoilex Ltd., specifically the Releaf Gel, in those diagnosed with atopic dermatitis. Patients will be routinely assessed via questionnaire, and physical measurements will be taken with respect to the affected area studied in order to judge clinical efficacy. The main question[s] it aims to answer are: Did you experience an immediate increase in skin hydration? Did you experience a soothing or comforting feeling on your irritated skin area? Please explain where your affected area is located, and also include at what time point this occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application Upon the affected area being in the healing phase, was your skin itch/scratch free for 4/6/10/12 hours (please circle)? Did you experience immediate relief from your skin inflammation? Did the study cream absorb quickly into your skin, without any greasy feeling? Has your skin flare disappeared in 2 week(s)? Has your skin condition appearance improved? (Yes/No) Participants will apply Phoilex Releaf Gel (a cream) to their affected areas of atopic dermatitis. The questions listed above shall be discussed and observations recorded at the 0 week, 1 week, 2 week, and 4 week time points. Additional monitoring questions may be asked of the participants to ensure the safety of the product. A chart will be provided to the participants to track Phoilex Releaf Gel usage (how many pumps, and time of day) throughout duration of the study. We hypothesize that Releaf gel will be suitable to ameliorate the common signs and symptoms of atopic dermatitis as well as improve patient quality of life.

First Posted: September 5, 2023

Condition(s): Atopic Dermatitis

Intervention(s): Phoilex Releaf Gel

Status: Recruiting

Enrollment (expected or actual): 30

Allocation:

Sponsor: Phoilex Ltd.

Principal Investigator:

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

CT.gov Identifier: NCT06022874

A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.

First Posted: July 24, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Guanfacine Extended Release Oral Tablet, Residential withdrawal, Engagement with alcohol and other drug services, Placebo

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Orygen

Principal Investigator:

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

CT.gov Identifier: NCT05957848

The aim of the study is to evaluate the effectiveness of an aqueous solution containing CBD and CBN in the management of Facial Pain and Headache of Muscular Origin. A randomized (block randomization), double-blind, two-arm controlled trial will involve 42 adult patients diagnosed with Facial Pain and Headache of Muscular Origin which is lasting more than 3 months on the basis of clinical examination. Qualified study participants will be randomly assigned to two groups. The studied group will receive tan aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician, while the control group will receive an aqueous solution of placebo, to drink at home in the dose determined by the attending physician during this time. Each subject will be tested on the qualification day (D0), on 20 days after D0 (D20), and then 40 (D40) and 60 (D60) days after the qualification day using electromyography (EMG), pressure pain threshold test (PPT), clinical examination and surveys.

First Posted: July 27, 2023

Condition(s): Myalgia, Muscle Pain, Orofacial Pain, Headache, Tension, Headaches Muscular, Headache

Intervention(s): An aqueous solution containing CBD and CBN, The aqueous solution of placebo

Status: Not yet recruiting

Enrollment (expected or actual): 42

Allocation: Randomized

Sponsor: Wroclaw Medical University

Principal Investigator: Joanna Smardz, Investigator

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT05961501

The goal of this interventional study is to learn about the effect of Medicinal Cannabis (Bedrocan®) on Fibromyalgia patients with pain resistant to conventional therapy. The main question the trial aims to answer are: Is Bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy? Can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain? All patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

First Posted: July 11, 2023

Condition(s): Fibromyalgia

Intervention(s): Bedrocan®-type cannabis (22% THC, <1% CBD)

Status: Completed

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: Universita degli Studi della Basilicata

Principal Investigator:

Completion Date (primary or actual): September 1, 2021

CT.gov Identifier: NCT05939466

This study will be a prospective observation of the use of commercially available hemp and cannabis products marketed for immune support.

First Posted: July 13, 2023

Condition(s): Influenza, COVID-19, Common Cold

Intervention(s): Immune Support Supplement

Status: Not yet recruiting

Enrollment (expected or actual): 200

Allocation:

Sponsor: Center For Interventional Pain and Spine

Principal Investigator:

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

CT.gov Identifier: NCT05944705

This is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications after a knee arthroscopy.

First Posted: July 7, 2023

Condition(s): Post-operative Pain

Intervention(s): Cannabidiol Oil

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Foundation for Orthopaedic Research and Education

Principal Investigator:

Completion Date (primary or actual): July 15, 2025

CT.gov Identifier: NCT05934500

This double-blind, placebo-controlled, crossover study aims to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of the main analgesic and psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), among older adults - the fastest growing population of cannabis consumers, and the most likely age cohort to use cannabinoids to relieve pain.

First Posted: June 18, 2023

Condition(s): Pain, Tolerance, Oral vs Vaporized THC, Abuse Liability

Intervention(s): Dronabinol 5 MG, Dronabinol 10 MG, 2mg Purified THC in an ethanolic solution, 4mg Purified THC in an ethanolic solution, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Assistant Professor of Psychiatry

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

CT.gov Identifier: NCT05906511

The number of youngsters abusing cannabis is surging, the public health consequences caused by cannabis can be unpredictable. Educating the public especially the young population about cannabis need to be highlighted. To successfully promote anti-cannabis messages to youngsters and prevent them from taking cannabis, the involvement of their parents and modern technology such as robots can be helpful. This project aims to educate the young population and their parents about cannabis, particularly its legal consequences and clarifying their misconceptions.

First Posted: June 12, 2023

Condition(s): Cannabis

Intervention(s): A community-based network training program

Status: Not yet recruiting

Enrollment (expected or actual): 200

Allocation: N/A

Sponsor: The Hong Kong Polytechnic University

Principal Investigator: Dr Katherine Lam, Research Assistant Professor

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

CT.gov Identifier: NCT05899946

The interface between cannabis use and stress is a particularly important focus for sex differences research in emerging adults. Given the dynamics at play in this critical stage when cannabis use is most prevalent, developmentally informed research is needed to guide tailored clinical interventions. This study will apply rigorous and innovative methods to elucidate sex differences in the nexus of cannabis use and stress among emerging adults with cannabis use disorder to guide the development of tailored treatments.

First Posted: June 2, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Cannabidiol oral solution, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 148

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Kevin Gray, MD, Professor-Faculty

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

CT.gov Identifier: NCT05885542

The purpose of this study is to learn about the effects of a cannabis-like substance, nabilone, on the levels of endocannabinoid enzyme fatty acid amide hydrolase (FAAH) in brain of healthy individuals. Using magnetic resonance imagine (MRI) and positron emission tomography (PET), the main questions we aim to answer are: 1) Does nabilone decrease levels of FAAH in the brain? and 2) Are changes in levels of FAAH associated with clinical response to nabilone? Participants will complete: An in-person interview (~4 hours) Two brain imaging scanning sessions (~11 hours) A one week 2 mg titrated dose of nabilone Virtual check-ins (up to ~1.5 hours)

First Posted: June 2, 2023

Condition(s): Healthy

Intervention(s): Nabilone Oral Capsule

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): June 2026

CT.gov Identifier: NCT05885685

The use of Cannabis is increasing in the population, and the effects that this might have on different medical procedures are poorly understood. Particularly when submitted to deep sedation or general anesthesia, there is no consensus on best drugs or doses to deliver. The purpose of this clinical trial is to clarify the influence of chronic cannabis use during office based general anesthesia for extraction of teeth. The procedures will be performed in the Oral and Maxillofacial Surgery Clinic at the College of Dentistry.

First Posted: May 24, 2023

Condition(s): Cannabis Use

Intervention(s): Sedation with Midazolam, Fentanyl, and Propofol, Extraction of teeth

Status: Not yet recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: University of Oklahoma

Principal Investigator:

Completion Date (primary or actual): May 21, 2024

CT.gov Identifier: NCT05873465