Purpose

This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 21-50 years old - Heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women) - Regular users of legal-market flower cannabis (at least 2x/week in past 3 months) - report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months - English speakers.

Exclusion Criteria

  • Daily tobacco users - Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD) - Females cannot be pregnant, breastfeeding or trying to become pregnant - Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) Current use of psychotropic (except anti-depressants) - Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment - Major medical condition contraindicating alcohol and/or cannabis consumption.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cannabis Group
Participants in this group will self-administer their own flower cannabis product (that they purchased for use in the study from a legal-market dispensary) ad libitum inside their homes. Researchers will not handle the product or instruct participants on how much to use during the session.
  • Other: Cannabis
    Participants in this group will self-administer legal-market flower cannabis
Experimental
Alcohol Group
Participants in this group will be administered a dose of alcohol by researchers in our mobile lab. The dose is designed (based on participant sex and body weight) to bring blood alcohol concentration to .06 g/dL.
  • Other: Alcohol
    Participants in this condition will receive the standard alcohol dose
Experimental
Alcohol + Cannabis Group
Participants in this group will first self-administer their own flower cannabis product (that they purchased for use in the study from a legal-market dispensary) ad libitum inside their homes. Researchers will not handle the product or instruct participants on how much to use during the session. They will then return to the mobile lab which will be parked outside their residence and will be administered a dose of alcohol by researchers. The dose is designed (based on participant sex and body weight) to bring blood alcohol concentration to .06 g/dL.
  • Other: Alcohol
    Participants in this condition will receive the standard alcohol dose
  • Other: Cannabis
    Participants in this group will self-administer legal-market flower cannabis

Recruiting Locations

Colorado State University
Fort Collins, Colorado 80523
Contact:
Hollis C. Karoly, PhD

More Details

Status
Recruiting
Sponsor
Colorado State University

Study Contact

Hollis C Karoly, PhD
970-491-3677
hollis.karoly@colostate.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.