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Behavioural Intervention

Alcohol + Cannabis Group for Alcohol Use Disorder

N/A

Recruiting

Led By Patricia Davies, PhD

Research Sponsored by Colorado State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

Awards & highlights

Study Summary

This trial aims to compare the effects of cannabis intoxication, alcohol intoxication, and co-intoxication (using both alcohol and cannabis) on the brain activity, breath alcohol levels, and balance of

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Since participants will be consuming alcohol and/or cannabis as part of the study, they may experience typical side effects such as dizziness, impaired coordination, altered perception, dry mouth or increased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 50 years old.

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I do not drink more than the specified limits for my gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately pre-substance use, 1-hour post-use, 2-hours post-use, 4-hours post-use for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electroencephalography (EEG) Objective Cognitive Function Measures--Amplitude (microvolts)

Electroencephalography (EEG) Objective Cognitive Function Measures--Latency (milliseconds)

Standing postural stability

Other outcome measures

Blood Cannabidiol (CBD) Levels

Blood Delta-9-tetrahydrocannabinol (THC) Levels

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

+2 more

Trial Design

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Colorado State UniversityLead Sponsor

125 Previous Clinical Trials

38,260 Total Patients Enrolled

Patricia Davies, PhDPrincipal InvestigatorColorado State University

Hollis Karoly, PhDPrincipal InvestigatorColorado State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific criteria must individuals meet to be eligible for enrollment in this clinical study?

"Candidates must be between 21 and 50 years old and have a diagnosis of alcohol use disorder to qualify for participation in this trial, which aims to recruit approximately 99 individuals."

Answered by AI

Is the enrollment for this trial currently open?

"Indeed, data from clinicaltrials.gov highlights the ongoing recruitment of participants for this investigation. The trial was initially listed on January 5th, 2024 and last modified on February 7th, 2024. Recruitment aims to enroll a total of 99 patients across a single site."

Answered by AI

What is the upper threshold for the number of individuals enrolled in this medical study?

"Yes, data on clinicaltrials.gov reveals that this medical investigation is actively seeking candidates. The trial was initially disclosed on the 5th of January in 2024 and last revised on the 7th of February in the same year. The study aims to recruit a total of 99 participants from one designated site."

Answered by AI