Actively Recruiting

Phase 2
Age: 21Years - 50Years
All Genders
Healthy Volunteers
ID05389930

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

Led by Brown University · Updated on 2024-08-06

350

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brown University

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different types of cannabis on alcohol consumption in heavy episodic drinkers who use cannabis weekly. This study compares the impact of THC-dominant cannabis, CBD-dominant cannabis, and placebo on subsequent drinking behavior using a repeated measures experimental design. Participants will receive cannabis simultaneously with either an alcohol-priming dose or an alcohol placebo, aiming to better understand how specific cannabinoids influence alcohol use and related risks. Participants will be randomized to receive one of several interventions: a THC-dominant cannabis dose (9.53% THC and 0.09% CBD), a CBD-dominant cannabis dose (0.35% THC and 11.27% CBD), or a placebo cannabis dose, all smoked using a handheld pipe. Alcohol will be given as a priming drink designed to raise blood alcohol levels to 0.03 g/dl or as a placebo beverage consisting mainly of juice with a trace of alcohol for masking. The study includes a baseline session, three experimental sessions, and a four-week follow-up period using a smartphone application to monitor participants in their natural environment. During the study, participants will complete alcohol choice tasks to measure the amount of alcohol consumed after smoking cannabis or placebo. Researchers will assess drinking behavior over two hours after cannabis use and track participants' alcohol use and related behaviors during the four-week follow-up. Safety measures include breath alcohol tests at each visit and monitoring for adherence to study protocols. The study aims to enroll up to 350 participants to achieve a final sample of 200 with complete data.

CONDITIONS

Brief Title

Cannabis' Impact on Alcohol Consumption

Who Can Participate

Age: 21Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 50 years
  • English-speaking
  • Smoked cannabis in the past two months
  • Engaged in heavy drinking in the past two months
  • In good physical health and weighing less than 250 lbs
  • Zero breath alcohol at each visit
Not Eligible

You will not qualify if you...

  • Positive pregnancy test
  • Currently nursing
  • Positive urine toxicology screen for drugs other than cannabis
  • Interest in quitting or receiving treatment for cannabis or alcohol use

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Session

Duration - 1 day

Participants complete initial assessments and baseline measurements before experimental sessions.

1 visit (in-person)

Experimental Sessions

Duration - 3 sessions over several weeks

Participants attend three sessions where they receive different cannabis and alcohol doses to assess effects on alcohol consumption.

3 visits (in-person)

Natural Environment Monitoring

Duration - 4 weeks

Participants are monitored for 4 weeks using a smartphone app to assess drinking behavior in their daily environment after experimental sessions.

Continuous monitoring via smartphone app

Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 02912

Actively Recruiting

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Research Team

J

Jane Metrik, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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