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Marijuana and Alcohol Effects on Driving Impairment (Alc-NHTSA Trial)

Phase < 1
Waitlist Available
Led By Godfrey Pearlson, M.D
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
history of head trauma with loss of consciousness > 30 minutes or concussion lasting 30 days.
any medical/neurological condition that could compromise neurocognitive performance (i.e. epilepsy, multiple sclerosis, fetal alcohol syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours

Summary

This trial looks at the effects of smoking marijuana and drinking alcohol on driving.

Who is the study for?
This trial is for adults who regularly drink alcohol and smoke marijuana, with at least 2 years of cannabis use and driving experience. They must not be novice users, should have used cannabis at least five times in their life without withdrawal symptoms, and hold a valid driver's license.
What is being tested?
The study tests the effects of different levels of marijuana (high to low) and alcohol (0.08 BAC to placebo) on simulated driving performance. It aims to understand how these substances combined can impair driving abilities.
What are the potential side effects?
Since this trial involves the consumption of marijuana and alcohol, side effects may include typical reactions such as dizziness, altered perception, coordination issues, delayed reaction times, euphoria or anxiety.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a head injury with unconsciousness for over 30 minutes or a concussion that lasted 30 days.
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I do not have conditions like epilepsy that affect my brain function.
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I do not have any serious illnesses like cancer, seizures, or brain diseases.
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I have been diagnosed with a mental health condition.
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A close family member has a psychotic disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ethanol
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task.
Ethanol
+13 more
Secondary study objectives
Change in concentration of THC/metabolites in blood samples.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Change in performance on simulated driving Car Following Task.
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo Drug + 0.08 BAC AlcExperimental Treatment2 Interventions
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08.
Group II: Placebo Drug + 0.05 BAC AlcExperimental Treatment2 Interventions
Participants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05.
Group III: Low Dose THC + 0.05 BAC AlcExperimental Treatment2 Interventions
Participants will receive low dose of THC along with alcohol leading to a BAC of 0.05.
Group IV: High Dose THC + 0.05 BAC AlcExperimental Treatment2 Interventions
Participants will receive high dose of THC along with alcohol leading to a BAC of 0.05.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

National Highway Traffic Safety AdministrationUNKNOWN
1 Previous Clinical Trials
26 Total Patients Enrolled
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,670 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
9 Patients Enrolled for Cannabis Intoxication
National Highway Traffic Safety Administration (NHTSA)FED
7 Previous Clinical Trials
929 Total Patients Enrolled

Media Library

High Marijuana, Hash, THC, or Grass Clinical Trial Eligibility Overview. Trial Name: NCT04856566 — Phase < 1
Cannabis Intoxication Research Study Groups: Low Dose THC + 0.05 BAC Alc, High Dose THC + 0.05 BAC Alc, Placebo Drug + 0.05 BAC Alc, Placebo Drug + 0.08 BAC Alc
Cannabis Intoxication Clinical Trial 2023: High Marijuana, Hash, THC, or Grass Highlights & Side Effects. Trial Name: NCT04856566 — Phase < 1
High Marijuana, Hash, THC, or Grass 2023 Treatment Timeline for Medical Study. Trial Name: NCT04856566 — Phase < 1
~1 spots leftby Apr 2025
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