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Cannabis' Impact on Alcohol Consumption

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ClinicalTrials.gov Identifier: NCT05389930
Recruitment Status : Not yet recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Brown University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alcohol Drinking Cannabis Use Cannabis Alcohol Use Disorder Drug: THC-dominant cannabis Drug: CBD-dominant cannabis Drug: Cannabis placebo Drug: Alcohol Drug: Alcohol placebo Phase 2

Detailed Description:
This study employs a repeated measures experimental design to examine the effect of THC-dominant (12.13% 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 12.13% THC/0.09% 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)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants are masked. Outcome assessors who have contact with participants are masked.
Primary Purpose: Basic Science
Official Title: Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Marijuana
Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: THC-dominant cannabis dose
292 mg of cannabis plant material with 12.13% THC and 0.09% CBD and 292 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol

Drug: Alcohol placebo
Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking

Experimental: CBD-dominant cannabis dose
292 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 292 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol

Drug: Alcohol placebo
Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking

Placebo Comparator: Placebo
584 mg of cannabis plant material will be smoked in a handheld pipe
Drug: Alcohol
Drink containing 0.3 g/kg of alcohol

Drug: Alcohol placebo
Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking

Experimental: Alcohol priming dose
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 fruit juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.
Drug: THC-dominant cannabis
Smoked cannabis with 12.13% THC and 0.09% CBD

Drug: CBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD

Drug: Cannabis placebo
Smoked placebo cannabis plant material

Placebo Comparator: Alcohol placebo dose
Placebo beverage contains only fruit 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.
Drug: THC-dominant cannabis
Smoked cannabis with 12.13% THC and 0.09% CBD

Drug: CBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD

Drug: Cannabis placebo
Smoked placebo cannabis plant material




Primary Outcome Measures :
  1. ml of alcohol consumed [ Time Frame: post-smoking during two-hours of the alcohol choice task ]
    ml of alcohol consumed during the alcohol choice task



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 to 50
  • English-speaking
  • cannabis smoking in past two months
  • heavy drinking in past two months
  • in good physical health and weighing < 250 lbs
  • zero breath alcohol at each visit

Exclusion Criteria:

  • positive pregnancy test
  • nursing
  • positive urine toxicology screen for drugs other than cannabis
  • interest to quit or receive treatment for cannabis or alcohol use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389930


Contacts
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Contact: Jane Metrik, PhD 401-863-6650 Jane_Metrik@brown.edu

Locations
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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Contact: Jane Metrik, PhD    401-863-6650    Jane_Metrik@brown.edu   
Sponsors and Collaborators
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jane Metrik, PhD Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT05389930    
Other Study ID Numbers: 2022003195
R01AA029711 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
alcohol
cannabis
marijuana
addiction
cannabinoid
tetrahydrocannabinol
cannabidiol
Additional relevant MeSH terms:
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Marijuana Abuse
Alcoholism
Alcohol Drinking
Drinking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs