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

Developing Predictive Models to Distinguish Alcohol Use, Cannabis Use and Co-use: An Exploration of Electroencephalography (EEG) Metrics and Traditional Intoxication Measures

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06259916

Enrollment

Registered

2024-02-14

Start date

2024-01-05

Completion date

2027-05-30

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Unspecified, Cannabis Use

Brief summary

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.

Interventions

OTHERAlcohol

Participants in this condition will receive the standard alcohol dose

OTHERCannabis

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use	The EEG amplitude (measured in microvolts) will be obtained while participants perform the speeded visual flanker task
Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use	The EEG latency (measured in milliseconds) will be obtained while participants perform the speeded visual flanker task
Standing postural stability	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use	An iPod Touch will be attached to each participant's hip with a simple elastic/Velcro strap. An app on the device will record fine grained movements while they try to stand as still as possible for 30-60 seconds under four conditions that vary in terms of demand on the proprioceptive system (eyes open, eyes closed), and on a stable vs. soft (foam) surface.

Countries

United States

Contacts

CONTACTHollis C Karoly, PhD

hollis.karoly@colostate.edu970-491-3677

CONTACTPatricia Davies, PhD

patricia.davies@colostate.edu(970) 491-7294

PRINCIPAL_INVESTIGATORHollis Karoly, PhD

Colorado State University

PRINCIPAL_INVESTIGATORPatricia Davies, PhD