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Marijuana's Impact on Alcohol Motivation and Consumption

Primary Purpose

Alcohol Drinking, Marijuana

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
THC 7.2%
THC 3.0%
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

Eligibility Criteria

21 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 21 to 44
  • English-speaking
  • marijuana smoking in past month
  • report of current heavy episodic (binge) drinking
  • in good physical health and weighing < 250 lbs
  • zero breath alcohol at each visit

Exclusion Criteria:

  • history of seizures
  • smoking >20 tobacco cigarettes per day
  • positive pregnancy test
  • nursing
  • positive urine toxicology screen for drugs other than cannabis
  • interest to quit or receive treatment for marijuana or alcohol use
  • meeting criteria for a current affective disorder (depression, or mania, panic disorder, and having psychotic symptoms as assessed by the SCID)

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High THC dose

Low THC dose

Placebo

Arm Description

1 marijuana cigarette (7.2% THC)

1 marijuana cigarette (3.0% THC)

Placebo marijuana cigarette

Outcomes

Primary Outcome Measures

change in alcohol craving
Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)

Secondary Outcome Measures

change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)
Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.
number of alcohol beverages consumed

Full Information

First Posted
November 15, 2016
Last Updated
September 22, 2021
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02983773
Brief Title
Marijuana's Impact on Alcohol Motivation and Consumption
Official Title
Marijuana's Impact on Alcohol Motivation and Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consume. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly.
Detailed Description
This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3.0% THC) dose of marijuana, relative to placebo, on alcohol craving and on behavioral economic measure of alcohol demand after exposure to alcohol cues, and on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5 alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory functioning. Several empirically-determined mechanisms that may explain why marijuana may increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final sample of 150 with complete data (15% of attrition). Participants will be tested at a baseline session and during three experimental sessions. Investigators will collect blood samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in hormones and other biomarkers potentially related to appetite, inflammation and stress. Collection of these biomarkers would allow for a greater understanding about the mechanisms whereby marijuana may acutely increase alcohol motivation and use. The findings will inform researchers and clinicians about how marijuana acutely increases alcohol craving and consumption. The strategy of this proposal is to use the most comprehensive controlled test characterizing marijuana's putative effects on alcohol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Marijuana

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High THC dose
Arm Type
Experimental
Arm Description
1 marijuana cigarette (7.2% THC)
Arm Title
Low THC dose
Arm Type
Experimental
Arm Description
1 marijuana cigarette (3.0% THC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo marijuana cigarette
Intervention Type
Drug
Intervention Name(s)
THC 7.2%
Intervention Description
1 smoked marijuana cigarette with 7.2% THC
Intervention Type
Drug
Intervention Name(s)
THC 3.0%
Intervention Description
1 smoked marijuana cigarette with 3.0% THC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 smoked placebo marijuana cigarette
Primary Outcome Measure Information:
Title
change in alcohol craving
Description
Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)
Time Frame
T1: pre-smoking (-45 minutes) and post smoking at 20 (T2), 55 (T3), and 70 (T4) minutes for a total of two hours during the experimental session
Secondary Outcome Measure Information:
Title
change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)
Description
Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.
Time Frame
T1: pre-smoking (-45 minutes) and post smoking at 55 (T2) and 70 (T3) minutes for a total of two hours during the experimental session
Title
number of alcohol beverages consumed
Time Frame
post-smoking during two-hour alcohol choice task during the experimental session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 21 to 44 English-speaking marijuana smoking in past month report of current heavy episodic (binge) drinking in good physical health and weighing < 250 lbs zero breath alcohol at each visit Exclusion Criteria: history of seizures smoking >20 tobacco cigarettes per day positive pregnancy test nursing positive urine toxicology screen for drugs other than cannabis interest to quit or receive treatment for marijuana or alcohol use meeting criteria for a current affective disorder (depression, or mania, panic disorder, and having psychotic symptoms as assessed by the SCID)
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

12. IPD Sharing Statement

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Marijuana's Impact on Alcohol Motivation and Consumption

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