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
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2024
CompletedFirst Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
February 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
November 13, 2025
November 1, 2025
2.4 years
January 9, 2024
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Other Outcomes (5)
Breath Alcohol Concentration
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Delta-9-tetrahydrocannabinol (THC) Levels
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Blood Cannabidiol (CBD) Levels
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
- +2 more other outcomes
Study Arms (3)
Cannabis Group
EXPERIMENTALParticipants 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.
Alcohol Group
EXPERIMENTALParticipants 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.
Alcohol + Cannabis Group
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Colorado State University
Fort Collins, Colorado, 80523, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hollis Karoly, PhD
Colorado State University
- PRINCIPAL INVESTIGATOR
Patricia Davies, PhD
Colorado State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
February 14, 2024
Study Start
January 5, 2024
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
November 13, 2025
Record last verified: 2025-11