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Cannabinoid

Ethanol + Cannabinoid Effects on DUI (THC-ETOH 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 and thc infusion

Summary

This trial will look at the effects of ethanol and cannabinoids on driving ability and related cognition.

Who is the study for?
This trial is for men and women aged 21 to 55 who have used cannabis and alcohol at least once. They must be able to understand and agree to the study's terms. Pregnant individuals, those who've never consumed alcohol or cannabis, or people with hearing problems cannot participate.
What is being tested?
The study aims to assess how ethanol (alcohol) and cannabinoids (like THC from cannabis) affect simulated driving performance and cognitive functions related to driving. Participants will receive either a placebo, active THC, or active ethanol during the trial.
What are the potential side effects?
Possible side effects may include impaired motor skills, altered perception, dizziness, delayed reaction times, difficulty concentrating or remembering things which are common effects of alcohol and THC.

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 and thc infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and +40 mins after start of alcohol and thc infusion for reporting.

Treatment Details

Study Objectives

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

Side effects data

From 2018 Phase 1 trial • 33 Patients • NCT01590277
7%
Nausea
7%
Vomiting
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Ethanol and Placebo Iomazenil
Active Ethanol and Placebo Iomazenil
Placebo Ethanol and Active Iomazenil
Active Ethanol and Active Iomazenil

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
Active Ethanol
2012
Completed Phase 1
~40

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

Active delta-9-THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT02404688 — Phase 1
Cannabis Research Study Groups: Placebo THC and Placebo Ethanol, Active THC and Placebo Ethanol, Placebo THC and Active Ethanol, Active THC and Active Ethanol
Cannabis Clinical Trial 2023: Active delta-9-THC Highlights & Side Effects. Trial Name: NCT02404688 — Phase 1
Active delta-9-THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02404688 — Phase 1
~0 spots leftby Dec 2024
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