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NCT Number: NCT05389930

Cannabis' Impact on Alcohol Consumption

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Location status: Recruiting

Location contact

Jane Metrik, PhD

CONTACT

[email protected]

401-863-6650

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THC-dominant cannabis

Drug

Smoked cannabis with 9.53% THC and 0.09% CBD

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

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Metrik, PhD

CONTACT

[email protected]

401-863-6650

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 25, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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