Cannabis' Impact on Alcohol Consumption

Alcohol Use Disorder Clinical Trial

Official title:

Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389930
• Other study ID #: 2022003195
• Secondary ID: R01AA029711
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2023
• Source: Brown University
• Contact: Jane Metrik, PhD
• Phone: 401-863-6650
• Email: Jane_Metrik[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Cannabis
• Cannabis Use
• Marijuana Abuse

Intervention

Drug:
• THC-dominant cannabis
Smoked cannabis with 9.53% THC and 0.09% CBD
• CBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD
• Cannabis placebo
Smoked placebo cannabis plant material
• Alcohol
Drink containing 0.3 g/kg of alcohol
• Alcohol placebo
Placebo beverage contains only juice and a negligible trace of alcohol for masking

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ml of alcohol consumed	ml of alcohol consumed during the alcohol choice task	post-smoking during two-hours of the alcohol choice task