NCT02983773

Brief Summary

This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2% THC) and moderate (3.1% 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 23, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

November 15, 2016

Results QC Date

September 12, 2025

Last Update Submit

March 31, 2026

Conditions

Alcohol DrinkingMarijuana

Outcome Measures

Primary Outcomes (1)

  • Alcohol Craving

    Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R) is a 12-item state measure of alcohol craving in the current moment (i.e., right now), scored on a 7-point Likert scale, from (1) strongly disagree to (7) strongly agree, with higher scores indicating greater craving. Scores on this measure are averaged to yield a total craving score.

    T0: pre-smoking (-45 minutes) and post smoking at 12 mins (T1), 47 mins (T2), and 58 mins (T3), 116 mins (T4), 178 mins (T5) during the experimental session

Secondary Outcomes (1)

  • Percent of Total Available Alcohol Consumed

    post-smoking during two-hour alcohol choice task during the experimental session

Study Arms (3)

7.2% THC

EXPERIMENTAL

1 marijuana cigarette (7.2% THC)

Drug: THC 7.2%

3.1% THC

EXPERIMENTAL

1 marijuana cigarette (3.1% THC)

Drug: THC 3.1%

Placebo

PLACEBO COMPARATOR

Placebo marijuana cigarette

Drug: Placebo

Interventions

THC 7.2%DRUG

1 smoked marijuana cigarette with 7.2% THC

7.2% THC
PlaceboDRUG

1 smoked placebo marijuana cigarette

Placebo
THC 3.1%DRUG

1 smoked marijuana cigarette with 3.0% THC

3.1% THC

Eligibility Criteria

Age21 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingMarijuana Abuse

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Jane Metrik, PhD
Organization
Brown University
Jane_Metrik@brown.edu
401-863-6650

Study Officials

  • Jane Metrik, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (research)

Study Record Dates

First Submitted

November 15, 2016

First Posted

December 6, 2016

Study Start

January 23, 2017

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

April 21, 2026

Results First Posted

April 21, 2026

Record last verified: 2026-03

Locations

US(1)