Alcohol + Cannabis for Intoxication Effects

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized clinical trial is to learn how alcohol use, cannabis use, and using both substances affect whether and how quickly people stop a video being shown to a woman. The study will recruit 312 people from the Metro-Denver area who drink alcohol and use cannabis; half of the participants will be women. The main questions it aims to answer are:

* How do alcohol, cannabis, and their combined use affect whether participants stop the video and how quickly they do so?

* Does alcohol use versus alcohol and cannabis use by others in the scenario affect whether and how quickly participants stop the video?

Researchers will compare four randomly assigned groups: alcohol only, cannabis only, both alcohol and cannabis, and neither substance. Participants will also be randomly assigned to one of two scenarios involving alcohol use or alcohol and cannabis use by others. These comparisons will help researchers understand how participants' own substance use and substance use by others affect their decisions to intervene.

Participants will:

* Complete a phone call to review the study and schedule a mobile laboratory visit at their home.

* Have their ID checked, complete a breath alcohol test to confirm no alcohol is in their system, and be weighed. Female participants will also take a pregnancy test.

* Provide written consent and complete questionnaires so researchers can confirm eligibility before random assignment.

* Follow their assigned substance-use condition. Participants in the cannabis-only group will smoke their usual cannabis at home while staff monitor them through Zoom. Those in the alcohol-only group will drink two weight-based alcoholic beverages, with a target blood alcohol concentration of 0.08%. Those assigned to both substances will use cannabis first and then drink alcohol. Those assigned to neither substance will not use either as part of the study.

* Provide blood and breath samples to measure cannabis-related THC and alcohol levels.

* Complete a task in which they can choose to stop a video being shown to a woman. Researchers will measure whether they stop the video and how long they take to do so.

* Take part in a recorded interview about their experience and the reasons they did or did not stop the video. Researchers will analyze these interviews to better understand how substance use affects decisions.

* Answer questions about what they believed the study was testing and their impressions of the other participants, receive an explanation of the study, and receive compensation.

Are You a Good Fit for This Trial?

This trial is for adults in the Metro-Denver area who regularly drink alcohol and use cannabis. Both men and women can join. Participants must be willing to use these substances as directed during the study, complete questionnaires, provide samples, and take part in interviews.

Inclusion Criteria

Smoked cannabis ≥ 3 days in the past year
Consume an alcohol quantity on a single occasion equal to or greater than the dose administered in the laboratory on ≥ 3 days in the past year
Provision of signed and dated informed consent form
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Exclusion Criteria

Experienced an adverse event while co-using alcohol and cannabis in the past 3 months
Currently being treated or in recovery for alcohol or drug problems or currently interested in seeking treatment for drinking or drug use via self-report
Any medical or psychiatric condition or current medication use contraindicating alcohol administration as determined by the Study Physician
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What Are the Treatments Tested in This Trial?

Trial Overview

The study randomly assigns participants to one of four groups: alcohol only, cannabis only (smoked), both alcohol and cannabis together, or neither substance. It examines how using these substances affects decisions while watching a video scenario.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Active Control

Group I: Cannabis Consumption + Alcohol/Cannabis Consumption of OthersExperimental Treatment2 Interventions
Group II: Cannabis Consumption + Alcohol Consumption of OthersExperimental Treatment2 Interventions
Group III: Alcohol/Cannabis Consumption + Alcohol/Cannabis Consumption of OthersExperimental Treatment2 Interventions
Group IV: Alcohol/Cannabis Consumption + Alcohol Consumption of OthersExperimental Treatment2 Interventions
Group V: Alcohol Consumption + Alcohol/Cannabis Consumption of OthersExperimental Treatment2 Interventions
Group VI: Alcohol Consumption + Alcohol Consumption of OthersExperimental Treatment2 Interventions
Group VII: Sober + Alcohol Consumption of OthersActive Control2 Interventions
Group VIII: Sober + Alcohol/Cannabis Consumption of OthersActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+