Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)

Colorado State University (CSU)

Status: Enrolling

Conditions: Cannabis Use; Alcohol Use, Unspecified

Treatments: Other: Cannabis; Other: Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT06259916

5061

Details and patient eligibility

About

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.

Enrollment: 99 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Cannabis Group

Experimental group

Description:

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.

Treatment:

Other: Cannabis

Alcohol Group

Experimental group

Description:

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.

Treatment:

Other: Alcohol

Alcohol + Cannabis Group

Experimental group

Description:

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.

Treatment:

Other: Alcohol

Other: Cannabis