99 Participants Needed

Alcohol and Cannabis Effects on Brain Activity

HC
PD
HC
Overseen ByHollis C. Karoly, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Colorado State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using psychotropic medications (except anti-depressants).

What data supports the effectiveness of EEG as a treatment for understanding the effects of alcohol and cannabis on brain activity?

Research shows that EEG can detect changes in brain wave patterns after alcohol consumption, such as increased power in certain frequency bands and changes in brain activity during mental tasks. Similarly, EEG can identify specific brain wave changes during cannabis intoxication, making it a useful tool for assessing the effects of these substances on the brain.12345

Is EEG safe for studying the effects of alcohol and cannabis on the brain?

EEG is a safe, non-invasive method used to study brain activity and has been used in research to assess the effects of substances like alcohol and cannabis on brain function.24567

How does EEG differ from other treatments for studying alcohol and cannabis effects on the brain?

EEG (Electroencephalography) is unique because it non-invasively measures brain wave activity in real-time, providing detailed insights into how alcohol and cannabis affect brain function, unlike other methods that may not capture these rapid changes.25689

Research Team

HK

Hollis C. Karoly, PhD

Principal Investigator

Colorado State University

PD

Patricia Davies, PhD

Principal Investigator

Colorado State University

Eligibility Criteria

This trial is for individuals who use alcohol, cannabis, or both and are interested in how these substances affect brain activity. Participants will be placed into groups to either consume alcohol, cannabis, or both in a controlled setting.

Inclusion Criteria

Regular users of legal-market flower cannabis (at least 2x/week in past 3 months)
English speakers
I am between 21 and 50 years old.
See 2 more

Exclusion Criteria

Daily tobacco users
Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment
Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to complete one study session in a mobile laboratory, using either alcohol, cannabis, or both, with EEG and other measures taken pre- and post-use

1 day
1 visit (in-person)

Follow-up

Participants are monitored for cognitive function and physiological measures immediately pre-use and at multiple intervals post-use

4 hours
Multiple assessments during the session

Treatment Details

Interventions

  • Electroencephalography
Trial OverviewThe study aims to distinguish the effects of alcohol intoxication, cannabis intoxication, and co-intoxication on brain activity using EEG. It's a randomized trial where participants' balance and breath alcohol levels are also measured.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cannabis GroupExperimental Treatment1 Intervention
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.
Group II: Alcohol GroupExperimental Treatment1 Intervention
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.
Group III: Alcohol + Cannabis GroupExperimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

Findings from Research

In a study of 24 young males, low doses of ethanol (0.75 mg/kg) significantly increased power in slower EEG frequency bands (4-7 Hz and 7.5-9 Hz) and reduced peak frequency in theta, fast alpha, and beta ranges, indicating changes in brain activity after alcohol consumption.
The subjective effects of ethanol varied based on individual baseline EEG patterns, with men showing higher fast alpha activity reporting less intoxication, suggesting that pre-existing brain activity may influence how alcohol affects perception and experience.
EEG spectral characteristics following ethanol administration in young men.Ehlers, CL., Wall, TL., Schuckit, MA.[2019]
Ethanol consumption (1.0 g/kg) in healthy young males led to increased power in theta and beta EEG bands, indicating altered brain activity, particularly in the left hemisphere, compared to a placebo group.
The study found that ethanol not only reduced the brain's ability to differentiate activity at rest but also impaired cognitive activation during a mental task, suggesting potential negative effects on cognitive function.
EEG topography of acute ethanol effects in resting and activated normals.Stenberg, G., Sano, M., Rosén, I., et al.[2019]
In a study involving 18 men, acute ethanol administration led to increased theta EEG activity that correlated with rising plasma ethanol levels, indicating a direct relationship between alcohol consumption and brain electrical activity changes.
The study found that increased alpha EEG activity was associated with feelings of intense pleasure or euphoria, suggesting that specific brain activity patterns are linked to the behavioral effects of ethanol.
EEG alpha activity increases during transient episodes of ethanol-induced euphoria.Lukas, SE., Mendelson, JH., Benedikt, RA., et al.[2019]

References

EEG spectral characteristics following ethanol administration in young men. [2019]
EEG topography of acute ethanol effects in resting and activated normals. [2019]
EEG alpha activity increases during transient episodes of ethanol-induced euphoria. [2019]
Ethanol-induced alterations in electroencephalographic activity in adult males. [2015]
Alterations in Electroencephalography Theta as Candidate Biomarkers of Acute Cannabis Intoxication. [2021]
Correlation of EEG biomarkers of cannabis with measured driving impairment. [2023]
The effects of ethanol on EEG activity in males at risk for alcoholism. [2019]
Occipital neural dynamics in cannabis and alcohol use: independent effects of addiction. [2022]
MEG and TMS combined with EEG for mapping alcohol effects. [2013]