12 Participants Needed

Marijuana and Alcohol Effects on Driving Impairment

(Alc-NHTSA Trial)

CB
DK
SA
Overseen BySuyash Adhikari, B.S
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.

Research Team

GP

Godfrey Pearlson, M.D

Principal Investigator

Founding Director, Olin Neuropsychiatry Center; Yale University

Eligibility Criteria

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.

Inclusion Criteria

You regularly smoke and drink alcohol.
I have used cannabis regularly for the past 2 years and experience its effects.
I have a driver's license and 2 years of recent highway driving experience.
See 1 more

Exclusion Criteria

I have had a head injury with unconsciousness for over 30 minutes or a concussion that lasted 30 days.
I do not have conditions like epilepsy that affect my brain function.
You have been diagnosed with a mental health condition according to the DSM-5.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive alcohol and marijuana doses followed by cognitive and simulated driving tests

4 days
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Laboratory Evaluations
  • Standardized Field Test for Marijuana and Alcohol Impairment
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Highway Traffic Safety Administration

Collaborator

Trials
2
Recruited
40+

National Highway Traffic Safety Administration (NHTSA)

Collaborator

Trials
8
Recruited
940+

Hartford Hospital

Collaborator

Trials
140
Recruited
19,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+
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