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

Cannabis Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259916
• Other study ID #: 5061
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: February 2024
• Source: Colorado State University
• Contact: Hollis C Karoly, PhD
• Phone: 970-491-3677
• Email: hollis.karoly[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Cannabis Use
• Marijuana Abuse

Intervention

Other:
• Alcohol
Participants in this condition will receive the standard alcohol dose
• Cannabis
Participants in this group will self-administer legal-market flower cannabis

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breath Alcohol Concentration	Measured using hand-held breathalyzer device	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Other	Blood Delta-9-tetrahydrocannabinol (THC) Levels	THC measured from blood samples	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Other	Blood Cannabidiol (CBD) Levels	CBD measured from blood samples	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Other	Blood Levels of 11-Nor-9-carboxy-?9-tetrahydrocannabinol (THC-COOH)	THC-COOH measured from blood samples	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Other	Blood Levels of 11-Hydroxy-?9-tetrahydrocannabinol (11-OH-THC)	11-OH-THC measured from blood samples	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Primary	Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)	The EEG amplitude (measured in microvolts) will be obtained while participants perform the speeded visual flanker task	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Primary	Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)	The EEG latency (measured in milliseconds) will be obtained while participants perform the speeded visual flanker task	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Primary	Standing postural stability	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.	Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use