Clinical trial NCT06259916: Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)
Official title: Developing Predictive Models to Distinguish Alcohol Use, Cannabis Use and Co-use: An Exploration of Electroencephalography (EEG) Metrics and Traditional Intoxication Measures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Alcohol Use, Unspecified
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Standing postural stability
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Secondary outcomes:
Other outcomes:
measure: Breath Alcohol Concentration
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Blood Delta-9-tetrahydrocannabinol (THC) Levels
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Blood Cannabidiol (CBD) Levels
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Blood Levels of 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
measure: Blood Levels of 11-Hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC)
timeFrame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Hollis Karoly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado State University
name: Patricia Davies, PhD
role: PRINCIPAL_INVESTIGATOR
References: