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

NCT ID: NCT06259916

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Use Alcohol Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cannabis

Intervention Type OTHER

Participants in this group will self-administer legal-market flower cannabis

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.

Group Type EXPERIMENTAL

Alcohol

Intervention Type OTHER

Participants in this condition will receive the standard alcohol dose

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.

Group Type EXPERIMENTAL

Alcohol

Intervention Type OTHER

Participants in this condition will receive the standard alcohol dose

Cannabis

Intervention Type OTHER

Participants in this group will self-administer legal-market flower cannabis

Interventions

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Alcohol

Participants in this condition will receive the standard alcohol dose

Intervention Type OTHER

Cannabis

Participants in this group will self-administer legal-market flower cannabis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hollis Karoly, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Patricia Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

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Colorado State University

Fort Collins, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hollis C Karoly, PhD

Role: CONTACT

Phone: 970-491-3677

Email: [email protected]

Patricia Davies, PhD

Role: CONTACT

Phone: (970) 491-7294

Email: [email protected]

Facility Contacts

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Hollis C. Karoly, PhD

Role: primary

Other Identifiers

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5061

Identifier Type: -

Identifier Source: org_study_id