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Cannabinoid
Alcohol + THC for DUI Effects (THC-ETOH-I 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 well alcohol and marijuana affect driving ability and cognition.
Who is the study for?
This trial is for occasional cannabis users aged 21-55 who have drunk alcohol at least once. They must understand the study and agree to participate. People can't join if they've never used cannabis or alcohol, have hearing problems, or are pregnant.
What is being tested?
The study aims to understand how ethanol (found in alcoholic drinks) and delta-9-THC (from cannabis) affect simulated driving and thinking skills. Participants will either receive active oral ethanol, a placebo, or inhale active THC.
What are the potential side effects?
Possible side effects may include impairment of motor coordination, altered judgment, changes in reaction time, dizziness, and potential cognitive impairments while under the influence of these substances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ +40 mins after start of alcohol administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~+40 mins after start of alcohol administration
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have hearing problems.I am between 21 and 55 years old.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Active THC and Placebo Ethanol
- Group 2: Placebo THC and Placebo Ethanol
- Group 3: Active THC and Active Ethanol
- Group 4: Placebo THC and Active Ethanol
Awards:
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