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

February 7, 2024 updated by: Colorado State University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Recruiting
        • Colorado State University
        • Contact:
          • Hollis C. Karoly, PhD
        • Principal Investigator:
          • Hollis C. Karoly, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Cannabis
Participants in this group will self-administer legal-market flower cannabis
Other: Alcohol
Participants in this condition will receive the standard alcohol dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)
Time Frame: 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
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)
Time Frame: 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
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Standing postural stability
Time Frame: 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.
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath Alcohol Concentration
Time Frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Measured using hand-held breathalyzer device
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Delta-9-tetrahydrocannabinol (THC) Levels
Time Frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
THC measured from blood samples
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Cannabidiol (CBD) Levels
Time Frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
CBD measured from blood samples
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Levels of 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)
Time Frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
THC-COOH measured from blood samples
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Levels of 11-Hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC)
Time Frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
11-OH-THC measured from blood samples
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Investigators

  • Principal Investigator: Hollis Karoly, PhD, Colorado State University
  • Principal Investigator: Patricia Davies, PhD, Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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