Cannabis UseNCT06259916
Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)
A study testing Alcohol and Cannabis in people with Cannabis Use and Alcohol Use, Unspecified, run by Colorado State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Alcohol Use, Unspecified
- What is being tested?
- Alcohol and Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Hollis C. Karoly, PhD
Hollis C. Karoly, PhD
About this study
Official title: 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.
- Conditions
- Cannabis Use, Alcohol Use, Unspecified
- Being tested
- Alcohol, Cannabis
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholOther
Participants in this condition will receive the standard alcohol dose
CannabisOther
Participants in this group will self-administer legal-market flower cannabis
| Study group | Role | What they receive |
|---|---|---|
| Cannabis Group | Experimental | 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. Receives: Other: Cannabis |
| Alcohol Group | Experimental | 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. Receives: Other: Alcohol |
| Alcohol + Cannabis Group | Experimental | 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. Receives: Other: Alcohol; Other: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start5 Jan 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hollis Karoly, PhD, Principal investigator, Colorado State UniversityPatricia Davies, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259916
- Sponsor's protocol ID
- 5061
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hetelekides EM, Davies PL, Prince MA, Gavin WJ, Karoly HC. Neurophysiological and Behavioural Effects of Combined Cannabis Concentrates and Alcohol Among People Who Regularly Use Alcohol and Cannabis. Addict Biol. 2026 Nov;31(11):e70194. doi: 10.1111/adb.70194.
PubMed 42935284
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Predictive Models to Distinguish Alcohol Use, Cannabis Use and Co-use: An Exploration of Electroencephalography (EEG) Metrics and Traditional Intoxication Measures
- ClinicalTrials.gov ID
- NCT06259916
- Acronym / sponsor ID
- 5061
- Conditions
- Cannabis Use, Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabis Group | Experimental | Other: CannabisParticipants 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 | Experimental | Other: AlcoholParticipants 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 | Experimental | Other: Alcohol, Other: CannabisParticipants 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholParticipants in this condition will receive the standard alcohol dose | Other | Alcohol + Cannabis Group, Alcohol Group |
| CannabisParticipants in this group will self-administer legal-market flower cannabis | Other | Alcohol + Cannabis Group, Cannabis Group |
Primary outcome
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 42935284Hetelekides EM, Davies PL, Prince MA, Gavin WJ, Karoly HC. Neurophysiological and Behavioural Effects of Combined Cannabis Concentrates and Alcohol Among People Who Regularly Use Alcohol and Cannabis. Addict Biol. 2026 Nov;31(11):e70194. doi: 10.1111/adb.70194.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hollis Karoly, PhD principal investigator
Colorado State University
Patricia Davies, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol and Cannabis in people with Cannabis Use and Alcohol Use, Unspecified, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hollis C Karoly, PhD (970-491-3677, hollis.karoly@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.