Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AA029711 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo.
The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.
This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THC-dominant cannabis dose | Experimental | 367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe |
|
| CBD-dominant cannabis dose | Experimental | 367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe |
|
| Placebo | Placebo Comparator | 584 mg of cannabis plant material will be smoked in a handheld pipe |
|
| Alcohol priming dose | Experimental | Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. |
|
| Alcohol placebo dose | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC-dominant cannabis | Drug | Smoked cannabis with 9.53% THC and 0.09% CBD |
|
| Measure | Description | Time Frame |
|---|---|---|
| ml of alcohol consumed | ml of alcohol consumed during the alcohol choice task | post-smoking during two-hours of the alcohol choice task |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Metrik, PhD | Contact | 401-863-6650 | Jane_Metrik@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jane Metrik, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Recruiting | Providence | Rhode Island | 02912 | United States |
Not provided
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D002189 | Marijuana Abuse |
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 9.53% THC/0.06% CBD, 11.27% CBD/0.35% THC, placebo) X 2 (between-subjects; cannabis + an alcohol-priming dose (0.3 g/kg) versus cannabis + alcohol placebo)
Not provided
Not provided
Participants are masked. Outcome assessors who have contact with participants are masked.
Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.
|
| CBD-dominant cannabis | Drug | Smoked cannabis with 0.35% THC and 11.27% CBD |
|
| Cannabis placebo | Drug | Smoked placebo cannabis plant material |
|
| Alcohol | Drug | Drink containing 0.3 g/kg of alcohol |
|
| Alcohol placebo | Drug | Placebo beverage contains only juice and a negligible trace of alcohol for masking |
|
| D001523 |
| Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |