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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Alcohol placebo
2009
Completed Phase 1
~30
Ethanol
FDA approved

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,004 Total Patients Enrolled
1 Trials studying Cannabis Use
60 Patients Enrolled for Cannabis Use
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,364,935 Total Patients Enrolled
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for candidates in this clinical trial?

"The clinical trial is not recruiting patients right now but was last updated on May 20th, 2022. There are other 504 trials that are open for recruitment."

Answered by AI

For which type of patient is this research appropriate?

"Eligible participants for this trial must be 21-50 years old, speak English, have smoked cannabis in the past 2 months, and have been heavy drinkers during that same time period. Candidates also cannot weigh more than 250lbs and must pass a breathalyzer test at each visit."

Answered by AI

Could you please explain the risks of THC-rich cannabis for patients?

"There is some data backing the safety of THC-dominant cannabis, but as this is only a Phase 2 trial, meaning that there is no evidence yet of efficacy, it receives a score of 2."

Answered by AI

Are octogenarians being sought for this trial?

"From the eligibility criteria, we can see that this study is for people aged 21-50. There are 50 studies involving patients under 18 and 309 with senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Kansas
District of Columbia
Other
How old are they?
18 - 65
What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Cannabis' Impact on Alcohol Consumption
2023. "Cannabis' Impact on Alcohol Consumption". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05389930.
All > Opiate Addiction > Addiction
~233 spots leftby Mar 2027
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