Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorColorado State University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Alcohol
Other interventionParticipants in this condition will receive the standard alcohol dose
Cannabis
Other interventionParticipants in this group will self-administer legal-market flower cannabis
Treatment groups
99 Participants
are divided into 3 treatment groupsGroup A: Cannabis GroupExperimental treatment 1 intervention
Group B: Alcohol GroupExperimental treatment 1 intervention
Group C: Alcohol + Cannabis GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use2
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
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use3
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.
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-useOther outcomes
1
Breath Alcohol Concentration
Measured using hand-held breathalyzer device
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use2
Blood Delta-9-tetrahydrocannabinol (THC) Levels
THC measured from blood samples
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use3
Blood Cannabidiol (CBD) Levels
CBD measured from blood samples
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use4
Blood Levels of 11-Nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH)
THC-COOH measured from blood samples
Time frame
Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-useSponsors and contacts
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Source ClinicalTrials.gov