Alcohol DrinkingPhase 2NCT02983773
Marijuana's Impact on Alcohol Motivation and Consumption
A Phase 2 study testing THC 7.2% and THC 3.1% in people with Alcohol Drinking and Marijuana, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Marijuana
- What is being tested?
- THC 7.2% and THC 3.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 21 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 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.
- Conditions
- Alcohol Drinking, Marijuana
- Being tested
- THC 7.2%, THC 3.1%, Placebo
- Medical subject headings
- Alcohol Drinking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC 7.2%Drug
1 smoked marijuana cigarette with 7.2% THC
THC 3.1%Drug
1 smoked marijuana cigarette with 3.0% THC
PlaceboDrug
1 smoked placebo marijuana cigarette
| Study group | Role | What they receive |
|---|---|---|
| 7.2% THC | Experimental | 1 marijuana cigarette (7.2% THC) Receives: Drug: THC 7.2% |
| 3.1% THC | Experimental | 1 marijuana cigarette (3.1% THC) Receives: Drug: THC 3.1% |
| Placebo | Placebo comparator | Placebo marijuana cigarette Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants completed two 60-minute blocks in the bar lab, during which they could drink up to eight mini-drinks of their personal choice with total amount of alcohol available designed to raise blood levels up to 0.10 g/dl or receive monetary reinforcement (in each block $12 tab in which each drink is worth $3) for drinks not consumed. The primary dependent variable for this task is percent of total available alcohol consumed.
Measured: post-smoking during two-hour alcohol choice task during the experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start23 Jan 2017
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jane Metrik, Brown University
- Investigators
- Jane Metrik, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983773
- Sponsor's protocol ID
- 1511001372
- Other IDs
- R01AA024091
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2016
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Metrik J, Aston ER, Gunn RL, Swift R, MacKillop J, Kahler CW. Acute Effects of Cannabis on Alcohol Craving and Consumption: A Randomized Controlled Crossover Trial. Am J Psychiatry. 2026 Feb 1;183(2):134-143. doi: 10.1176/appi.ajp.20250115. Epub 2025 Nov 19.
PubMed 41254853
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana's Impact on Alcohol Motivation and Consumption
- ClinicalTrials.gov ID
- NCT02983773
- Acronym / sponsor ID
- 1511001372
- Conditions
- Alcohol Drinking, Marijuana
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7.2% THC | Experimental | Drug: THC 7.2%1 marijuana cigarette (7.2% THC) |
| 3.1% THC | Experimental | Drug: THC 3.1%1 marijuana cigarette (3.1% THC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo marijuana cigarette |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- history of seizures
- smoking >20 tobacco cigarettes per day
- positive pregnancy test
- nursing
- positive urine toxicology screen for drugs other than cannabis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC 7.2%1 smoked marijuana cigarette with 7.2% THC | Drug | 7.2% THC |
| THC 3.1%1 smoked marijuana cigarette with 3.0% THC | Drug | 3.1% THC |
| Placebo1 smoked placebo marijuana cigarette | Drug | Placebo |
Primary outcome
Alcohol Craving
Time frame: 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
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.
1 secondary outcome
Percent of Total Available Alcohol Consumed
Time frame: post-smoking during two-hour alcohol choice task during the experimental session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41254853Metrik J, Aston ER, Gunn RL, Swift R, MacKillop J, Kahler CW. Acute Effects of Cannabis on Alcohol Craving and Consumption: A Randomized Controlled Crossover Trial. Am J Psychiatry. 2026 Feb 1;183(2):134-143. doi: 10.1176/appi.ajp.20250115. Epub 2025 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Metrik, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THC 7.2% and THC 3.1% in people with Alcohol Drinking and Marijuana, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Craving (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.