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Alcohol + Cannabinoid Effects on DUI (THC-ETOH-III Trial)

Phase 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females 21 to 55 years of age (extremes included)
Be between 18 and 65 years old
Must not have
Hearing deficits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, +120 mins after start of dronabinol administration

Summary

This trial looks at how alcohol and marijuana affect driving ability and cognition.

Who is the study for?
This trial is for men and women aged 21 to 55 who have used alcohol and cannabis at least once. They must be able to understand and agree to the study's terms. Pregnant individuals, those with hearing issues, no prior use of cannabis or alcohol (naïve), or a sesame oil allergy cannot participate.
What is being tested?
The study aims to assess how active Dronabinol (a synthetic THC), ethanol (alcohol), and placebo affect simulated driving performance and related thinking skills. Participants will receive these substances in a controlled environment.
What are the potential side effects?
Possible side effects may include impaired motor coordination, altered judgment, changes in cognition that could affect driving simulation performance, dizziness, dry mouth from Dronabinol; intoxication symptoms from Ethanol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have hearing problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, +120 mins after start of dronabinol administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, +120 mins after start of dronabinol administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline: Biphasic Alcohol Effects Scale (BAES)
Change from Baseline: Cognitive Test Battery
Change from Baseline: Number of Drinks Scale
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo THC and Active EthanolExperimental Treatment2 Interventions
Group II: Active THC and Placebo EthanolExperimental Treatment2 Interventions
Group III: Active THC and Active EthanolExperimental Treatment2 Interventions
Group IV: Placebo THC and Placebo EthanolPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Dronabinol
2016
Completed Phase 1
~20
Active Ethanol
2012
Completed Phase 1
~40
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,922 Previous Clinical Trials
3,031,502 Total Patients Enrolled
14 Trials studying Cannabis
784 Patients Enrolled for Cannabis

Media Library

Cannabis Research Study Groups: Active THC and Placebo Ethanol, Active THC and Active Ethanol, Placebo THC and Active Ethanol, Placebo THC and Placebo Ethanol
~0 spots leftby Dec 2024
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