Recruiting
Phase 2

Cannabis

Sponsor:

Brown University

Code:

NCT05389930

Conditions

Alcohol Drinking

Cannabis Use

Cannabis

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

THC-dominant cannabis

CBD-dominant cannabis

Cannabis placebo

Alcohol

Alcohol placebo

Study Details

Brief summary:

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo.

The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

Conditions

Alcohol Drinking

Cannabis Use

Cannabis

Alcohol Use Disorder

Study ID

NCT05389930

Start date

Mar 16, 2023

Status verified date

Aug, 2024

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 21 to 50
  • English-speaking
  • cannabis smoking in past two months
  • heavy drinking in past two months
  • in good physical health and weighing < 250 lbs
  • zero breath alcohol at each visit

Exclusion Criteria:

  • positive pregnancy test
  • nursing
  • positive urine toxicology screen for drugs other than cannabis
  • interest to quit or receive treatment for cannabis or alcohol use

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: THC-dominant cannabis dose

367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe

experimental: CBD-dominant cannabis dose

367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe

placebo comparator: Placebo

584 mg of cannabis plant material will be smoked in a handheld pipe

experimental: Alcohol priming dose

Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.

placebo comparator: Alcohol placebo dose

Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.

Interventions

THC-dominant cannabis

Smoked cannabis with 9.53% THC and 0.09% CBD

CBD-dominant cannabis

Smoked cannabis with 0.35% THC and 11.27% CBD

Cannabis placebo

Smoked placebo cannabis plant material

Alcohol

Drink containing 0.3 g/kg of alcohol

Alcohol placebo

Placebo beverage contains only juice and a negligible trace of alcohol for masking

Primary outcome measure

  • ml of alcohol consumed [ Time Frame: post-smoking during two-hours of the alcohol choice task ]

Central Contacts and Locations

Central contacts

Jane Metrik, PhD

401-863-6650Jane_Metrik@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Jane Metrik, PhD

401-863-6650Jane_Metrik@brown.edu

More Information

Sponsor

Brown University

Last update posted

Aug 6, 2024

Last verified

Aug, 2024

Keywords

  • alcohol
  • cannabis
  • marijuana
  • addiction
  • cannabinoid
  • tetrahydrocannabinol
  • cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2024-08-06.