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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

Approved for 5 Other Conditions

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-smoking during two-hours of the alcohol choice task

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

0 / 2Eligibility criteria met