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Cannabis' Impact on Alcohol Consumption

Primary Purpose

Alcohol Drinking, Cannabis Use, Cannabis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
THC-dominant cannabis
CBD-dominant cannabis
Cannabis placebo
Alcohol
Alcohol placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Drinking focused on measuring alcohol, cannabis, marijuana, addiction, cannabinoid, tetrahydrocannabinol, cannabidiol

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

THC-dominant cannabis dose

CBD-dominant cannabis dose

Placebo

Alcohol priming dose

Alcohol placebo dose

Arm Description

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

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

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

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.

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.

Outcomes

Primary Outcome Measures

ml of alcohol consumed
ml of alcohol consumed during the alcohol choice task

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
March 30, 2023
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05389930
Brief Title
Cannabis' Impact on Alcohol Consumption
Official Title
Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Cannabis Use, Cannabis, Alcohol Use Disorder
Keywords
alcohol, cannabis, marijuana, addiction, cannabinoid, tetrahydrocannabinol, cannabidiol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
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)
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are masked. Outcome assessors who have contact with participants are masked.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THC-dominant cannabis dose
Arm Type
Experimental
Arm Description
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
Arm Title
CBD-dominant cannabis dose
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
584 mg of cannabis plant material will be smoked in a handheld pipe
Arm Title
Alcohol priming dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Alcohol placebo dose
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
THC-dominant cannabis
Intervention Description
Smoked cannabis with 9.53% THC and 0.09% CBD
Intervention Type
Drug
Intervention Name(s)
CBD-dominant cannabis
Intervention Description
Smoked cannabis with 0.35% THC and 11.27% CBD
Intervention Type
Drug
Intervention Name(s)
Cannabis placebo
Intervention Description
Smoked placebo cannabis plant material
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Drink containing 0.3 g/kg of alcohol
Intervention Type
Drug
Intervention Name(s)
Alcohol placebo
Intervention Description
Placebo beverage contains only juice and a negligible trace of alcohol for masking
Primary Outcome Measure Information:
Title
ml of alcohol consumed
Description
ml of alcohol consumed during the alcohol choice task
Time Frame
post-smoking during two-hours of the alcohol choice task

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Metrik, PhD
Phone
401-863-6650
Email
Jane_Metrik@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Metrik, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Metrik, PhD
Phone
401-863-6650
Email
Jane_Metrik@brown.edu

12. IPD Sharing Statement

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Cannabis' Impact on Alcohol Consumption

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