Cannabis' Impact on Alcohol Consumption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) 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 to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.

Conditions

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Alcohol Drinking Cannabis Use Cannabis Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants are masked. Outcome assessors who have contact with participants are masked.

Study Groups

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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

Group Type EXPERIMENTAL

Alcohol

Intervention Type DRUG

Drink containing 0.3 g/kg of alcohol

Alcohol placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Alcohol

Intervention Type DRUG

Drink containing 0.3 g/kg of alcohol

Alcohol placebo

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Alcohol

Intervention Type DRUG

Drink containing 0.3 g/kg of alcohol

Alcohol placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

THC-dominant cannabis

Intervention Type DRUG

Smoked cannabis with 9.53% THC and 0.09% CBD

CBD-dominant cannabis

Intervention Type DRUG

Smoked cannabis with 0.35% THC and 11.27% CBD

Cannabis placebo

Intervention Type DRUG

Smoked placebo cannabis plant material

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.

Group Type PLACEBO_COMPARATOR

THC-dominant cannabis

Intervention Type DRUG

Smoked cannabis with 9.53% THC and 0.09% CBD

CBD-dominant cannabis

Intervention Type DRUG

Smoked cannabis with 0.35% THC and 11.27% CBD

Cannabis placebo

Intervention Type DRUG

Smoked placebo cannabis plant material

Interventions

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THC-dominant cannabis

Smoked cannabis with 9.53% THC and 0.09% CBD

Intervention Type DRUG

CBD-dominant cannabis

Smoked cannabis with 0.35% THC and 11.27% CBD

Intervention Type DRUG

Cannabis placebo

Smoked placebo cannabis plant material

Intervention Type DRUG

Alcohol

Drink containing 0.3 g/kg of alcohol

Intervention Type DRUG

Alcohol placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes