Verified December 2016 by Brown University
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jane Metrik, Brown University
ClinicalTrials.gov Identifier:
NCT02983773
First received: November 15, 2016
Last updated: December 5, 2016
Last verified: December 2016
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.
| Alcohol Drinking Marijuana |
Drug: THC 7.2% Drug: THC 3.0% Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Marijuana’s Impact on Alcohol Motivation and Consumption |
| Estimated Enrollment: | 173 |
| Study Start Date: | December 2016 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
| Experimental: High THC dose
1 marijuana cigarette (7.2% THC) |
Drug: THC 7.2%
1 smoked marijuana cigarette with 7.2% THC |
| Experimental: Low THC dose
1 marijuana cigarette (3.0% THC) |
Drug: THC 3.0%
1 smoked marijuana cigarette with 3.0% THC |
| Placebo Comparator: Placebo
Placebo marijuana cigarette |
Drug: Placebo
1 smoked placebo marijuana cigarette |
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.
| Ages Eligible for Study: | 21 Years to 44 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 21 to 44
- English-speaking
- marijuana use at least twice weekly in past month and at least weekly for past 6 months and smoking is a familiar route of self-administration of marijuana
- report of current heavy episodic (binge) drinking (>5 drinks for men and >4 drinks for women per occasion at least twice a month over the last 12 months) -ability to abstain from alcohol and marijuana for 24 hours without withdrawal (Clinical Institute Withdrawal Assessment for Alcohol, revised-CIWA-AR score < 8 at each visit)
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02983773
| Contact: Jane Metrik, PhD | 4018636650 | ||
| Contact: Julia Wood, NP | (401) 863-6631 |
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
| Principal Investigator: | Jane Metrik, PhD | Brown University |
| Responsible Party: | Jane Metrik, Assistant Professor (research), Brown University |
| ClinicalTrials.gov Identifier: | NCT02983773 History of Changes |
| Other Study ID Numbers: | 1511001372 R01AA024091 |
| Study First Received: | November 15, 2016 |
| Last Updated: | December 5, 2016 |
| Health Authority: | United States: Food and Drug Administration United States: Brown University Human Research Protection Program United States: National Institute on Alcohol Abuse and Alcoholism |
Additional relevant MeSH terms:
| Marijuana Abuse Alcohol Drinking Substance-Related Disorders |
Chemically-Induced Disorders Mental Disorders Drinking Behavior |
ClinicalTrials.gov processed this record on December 06, 2016