Cannabis' Impact on Alcohol Consumption

March 30, 2023 updated by: Brown University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Recruiting
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol
Drug: Alcohol placebo
Placebo beverage contains only juice and a negligible trace of alcohol for masking
Experimental: 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
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol
Drug: Alcohol placebo
Placebo beverage contains only juice and a negligible trace of alcohol for masking
Placebo Comparator: Placebo
584 mg of cannabis plant material will be smoked in a handheld pipe
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol
Drug: Alcohol placebo
Placebo beverage contains only juice and a negligible trace of alcohol for masking
Experimental: 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.
Drug: THC-dominant cannabis
Smoked cannabis with 9.53% THC and 0.09% CBD
Drug: CBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD
Drug: Cannabis placebo
Smoked placebo cannabis plant material
Placebo Comparator: 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.
Drug: THC-dominant cannabis
Smoked cannabis with 9.53% THC and 0.09% CBD
Drug: CBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD
Drug: Cannabis placebo
Smoked placebo cannabis plant material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ml of alcohol consumed
Time Frame: post-smoking during two-hours of the alcohol choice task
ml of alcohol consumed during the alcohol choice task
post-smoking during two-hours of the alcohol choice task

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Anticipated)

March 31, 2027

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022003195
  • R01AA029711 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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