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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA024091 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.2% THC | Experimental | 1 marijuana cigarette (7.2% THC) |
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| 3.1% THC | Experimental | 1 marijuana cigarette (3.1% THC) |
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| Placebo | Placebo Comparator | Placebo marijuana cigarette |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC 7.2% | Drug | 1 smoked marijuana cigarette with 7.2% THC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Metrik, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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157 participants were randomized to the experimental session order at the first experimental session and all completed the first experimental session. 131 participants completed all three experimental sessions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 7.2% THC Cigarette, Then Placebo Cigarette, Then 3.1% THC Cigarette | Participants smoke 1 cannabis cigarette with 7.2% THC, followed by placebo cigarette, followed by 1 cannabis cigarette with 3.1% THC on three separate experimental days. |
| FG001 | Placebo Cigarette, Then 3.1% THC Cigarette, Then 7.2% THC Cigarette | Participants smoke 1 placebo cigarette, followed by 1 cannabis cigarette with 3.1% THC, followed by 1 cannabis cigarette with 7.2% THC on three separate experimental days. |
| FG002 | 3.1% THC Cigarette, Then 7.2% THC Cigarette, Then Placebo Cigarette | Participants smoke 1 cannabis cigarette with 3.1% THC, followed by 1 cannabis cigarette with 7.2% THC, followed by 1 placebo cigarette on three separate experimental days. |
| FG003 | 7.2% THC Cigarette, Then 3.1% THC Cigarette, Then Placebo Cigarette | Participants smoke 1 cannabis cigarette with 7.2% THC, followed by 1 cannabis cigarette with 3.1% THC, followed by placebo cigarette on three separate experimental days. |
| FG004 | Placebo Cigarette, Then 7.2% THC Cigarette, Then 3.1% THC Cigarette | Participants smoke 1 placebo cigarette, followed by 1 cannabis cigarette with 7.2% THC, followed by 1 cannabis cigarette with 3.1% THC on three separate experimental days. |
| FG005 | 3.1% THC Cigarette, Then Placebo Cigarette, Then 7.2% THC Cigarette | Participants smoke 1 cannabis cigarette with 3.1% THC, followed by 1 placebo cigarette, followed by 1 cannabis cigarette with 7.2% THC on three separate experimental days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Overall sample of randomized participants (N = 157) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results are based on 138 participants, who completed at least two experimental sessions; 138 completed the placebo session, 134 completed the 3.1% THC session, and 134 completed the 7.2% THC session. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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AEs were monitored following the randomization through study completion, an average of 24 days.
Study-related Adverse Events are reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 7.2% THC | 1 marijuana cigarette (7.2% THC) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| elevated anxiety response after cannabis smoking | Psychiatric disorders | Systematic Assessment | Participant experienced an acute increase in anxiety following cannabis smoking. This reaction was transient, anticipated, not serious, and study-related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Metrik, PhD | Brown University | 401-863-6650 | Jane_Metrik@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2025 | Sep 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2020 | Sep 21, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| THC 3.1% |
| Drug |
1 smoked marijuana cigarette with 3.0% THC |
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| Placebo | Drug | 1 smoked placebo marijuana cigarette |
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| post-smoking during two-hour alcohol choice task during the experimental session |
| Pregnancy |
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| Adverse Event |
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| Protocol Violation |
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| Lost to Follow-up |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Low THC Dose | 1 marijuana cigarette (3.0% THC) THC 3.0%: 1 smoked marijuana cigarette with 3.0% THC |
| OG002 | Placebo | Placebo marijuana cigarette Placebo: 1 smoked placebo marijuana cigarette |
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| Secondary | 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. | Results are based on 138 participants, who completed at least two experimental sessions; 138 completed the placebo session, 134 completed the 3.1% THC session, and 134 completed the 7.2% THC session. | Posted | Mean | Standard Error | percent (range 0 to 100) | post-smoking during two-hour alcohol choice task during the experimental session |
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|
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| 157 |
| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | 3.1% THC | 1 marijuana cigarette (3.1% THC) | 0 | 157 | 0 | 157 | 1 | 157 |
| EG002 | Placebo | Placebo marijuana cigarette | 0 | 157 | 0 | 157 | 0 | 157 |
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| D001523 |
| Mental Disorders |