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RecruitingNCT06259916Updated Aug 11, 2026

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

An interventional study of Alcohol and Cannabis in Cannabis Use and Alcohol Use, Unspecified, sponsored by Colorado State University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Colorado State University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cannabis Use
  • Alcohol Use, Unspecified

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03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's planned enrollment of 99 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (estimated)

Study arms

  • 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

  • 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

  • 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: Alcohol · Other: Cannabis

Interventions

  • OtherAlcohol

    Participants in this condition will receive the standard alcohol dose

  • OtherCannabis

    Participants in this group will self-administer legal-market flower cannabis

06

What researchers measure

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-use

  2. 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-use

  3. 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-use

Other 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-use

  2. 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-use

  3. 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-use

  4. 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-use

  5. Blood Levels of 11-Hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC)

    11-OH-THC measured from blood samples

    Time frame: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

07

Study locations

1 of 1 sites recruiting
  • Colorado State University
    Fort Collins, Colorado 80523, United States
    Recruiting
    • Hollis C. Karoly, PhD · Contact
    • Hollis C. Karoly, PhD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for May 2027, 40 months after the start.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 40 months is above that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2024
First posted
Feb 14, 2024
StartActual
Jan 5, 2024
Primary completionEst.
May 30, 2027
CompletionEst.
May 30, 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06259916
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jan 5, 2024
Primary completion
May 30, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Hollis C Karoly, PhD
Contact
hollis.karoly@colostate.edu
970-491-3677
Patricia Davies, PhD
Contact
patricia.davies@colostate.edu
(970) 491-7294
Hollis Karoly, PhD
principal investigator · Colorado State University
Patricia Davies, PhD
principal investigator · Colorado State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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