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Cannabinoid

Ethanol + Cannabis Effects on DUI (THC-ETOH-II 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 +40 mins after start of alcohol administration

Summary

This trial will study how ethanol and cannabinoids affect driving ability and cognition.

Who is the study for?
This trial is for men and women aged 21-55 who occasionally use cannabis and have had at least two alcoholic drinks at some point. They must be able to consent to the study. People can't join if they've never used cannabis or alcohol, are pregnant, or have hearing problems.
What is being tested?
The study aims to understand how drinking alcohol (ethanol) and inhaling cannabis affect simulated driving and thinking skills. Participants will receive either a placebo, actual ethanol, or active inhaled cannabis to compare their effects.
What are the potential side effects?
Potential side effects may include impairment of motor coordination, altered judgment, changes in reaction time, dizziness, dry mouth from cannabis; while ethanol might cause drowsiness, headaches, nausea or impaired cognitive functions.

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 ~+40 mins after start of alcohol administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and +40 mins after start of alcohol 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
Biphasic Alcohol Effects Scale (BAES)
Cognitive Test Battery
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
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 (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT02710097 — Phase 1
Cannabis Research Study Groups: Active THC and Active Ethanol, Active THC and Placebo Ethanol, Placebo THC and Active Ethanol, Placebo THC and Placebo Ethanol
Cannabis Clinical Trial 2023: Cannabis Highlights & Side Effects. Trial Name: NCT02710097 — Phase 1
Cannabis (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02710097 — Phase 1
~0 spots leftby Dec 2024
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