Cannabis' Impact on Alcohol Consumption

NCT05389930 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2022003195R01AA029711
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Keywords

alcohol; cannabis; marijuana; addiction; cannabinoid; tetrahydrocannabinol; cannabidiol

Outcome Measures

Primary Outcomes (1)

• ml of alcohol consumed

  ml of alcohol consumed during the alcohol choice task

  post-smoking during two-hours of the alcohol choice task

Study Arms (5)

THC-dominant cannabis dose

EXPERIMENTAL

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

Drug: Alcohol; Drug: Alcohol placebo

CBD-dominant cannabis dose

EXPERIMENTAL

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

Drug: Alcohol; Drug: Alcohol placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Alcohol; Drug: Alcohol placebo

Alcohol priming dose

EXPERIMENTAL

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.

Drug: THC-dominant cannabis; Drug: CBD-dominant cannabis; Drug: Cannabis placebo

Alcohol placebo dose

PLACEBO COMPARATOR

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.

Drug: THC-dominant cannabis; Drug: CBD-dominant cannabis; Drug: Cannabis placebo

Interventions

THC-dominant cannabis DRUG

Smoked cannabis with 9.53% THC and 0.09% CBD

Alcohol placebo dose; Alcohol priming dose

CBD-dominant cannabis DRUG

Smoked cannabis with 0.35% THC and 11.27% CBD

Alcohol placebo dose; Alcohol priming dose

Cannabis placebo DRUG

Smoked placebo cannabis plant material

Alcohol placebo dose; Alcohol priming dose

Alcohol DRUG

Drink containing 0.3 g/kg of alcohol

CBD-dominant cannabis dose; Placebo; THC-dominant cannabis dose

Alcohol placebo DRUG

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

CBD-dominant cannabis dose; Placebo; THC-dominant cannabis dose

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking; Marijuana Abuse; Alcoholism; Behavior, Addictive

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jane Metrik, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Metrik, PhD

CONTACT

401-863-6650; Jane_Metrik@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are masked. Outcome assessors who have contact with participants are masked.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 9.53% THC/0.06% CBD, 11.27% CBD/0.35% THC, placebo) X 2 (between-subjects; cannabis + an alcohol-priming dose (0.3 g/kg) versus cannabis + alcohol placebo)

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: March 16, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)