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Cannabis for Alcoholism

Phase 2
Recruiting
Led By Jane Metrik, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 to 50
In good physical health and weighing less than 250 lbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-smoking during two-hours of the alcohol choice task
Awards & highlights

Summary

This trial will test the effects of THC- and CBD-dominant strains of cannabis on alcohol consumption.

Who is the study for?
This trial is for people aged 21-50 who are heavy drinkers and have smoked cannabis weekly in the past two months. They must be under 250 lbs, not pregnant or nursing, and not currently seeking treatment to quit alcohol or cannabis use.
What is being tested?
The study tests how THC-dominant and CBD-dominant cannabis doses affect participants' choice between drinking alcohol or receiving money as a reward for abstaining. It compares these effects with placebos in a controlled setting.
What are the potential side effects?
While specific side effects aren't listed, typical reactions might include changes in mood or perception from THC-cannabis, drowsiness or dry mouth from CBD-cannabis, and usual risks associated with alcohol consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 50 years old.
Select...
I am in good health and weigh under 250 lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-smoking during two-hours of the alcohol choice task
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-smoking during two-hours of the alcohol choice task for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ml of alcohol consumed

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: THC-dominant cannabis doseExperimental Treatment2 Interventions
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
Group II: CBD-dominant cannabis doseExperimental Treatment2 Interventions
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
Group III: Alcohol priming doseExperimental Treatment3 Interventions
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.
Group IV: PlaceboPlacebo Group2 Interventions
584 mg of cannabis plant material will be smoked in a handheld pipe
Group V: Alcohol placebo dosePlacebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved
Alcohol placebo
2009
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
463 Previous Clinical Trials
618,343 Total Patients Enrolled
1 Trials studying Cannabis Use
60 Patients Enrolled for Cannabis Use
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,160,956 Total Patients Enrolled
2 Trials studying Cannabis Use
160 Patients Enrolled for Cannabis Use
Jane Metrik, PhDPrincipal InvestigatorBrown University
2 Previous Clinical Trials
271 Total Patients Enrolled

Media Library

THC-dominant cannabis Clinical Trial Eligibility Overview. Trial Name: NCT05389930 — Phase 2
Cannabis Use Research Study Groups: Placebo, THC-dominant cannabis dose, CBD-dominant cannabis dose, Alcohol priming dose, Alcohol placebo dose
Cannabis Use Clinical Trial 2023: THC-dominant cannabis Highlights & Side Effects. Trial Name: NCT05389930 — Phase 2
THC-dominant cannabis 2023 Treatment Timeline for Medical Study. Trial Name: NCT05389930 — Phase 2
~219 spots leftby Mar 2027