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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
Awards & highlights

Alc-NHTSA Trial 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.Check my eligibility
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.See study design
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.

Alc-NHTSA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ethanol
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task.
Ethanol
+13 more
Secondary outcome measures
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

Alc-NHTSA 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
1,854 Previous Clinical Trials
2,740,549 Total Patients Enrolled
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 Impairment 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 Impairment 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions are most commonly alleviated by the use of High Marijuana, Hash, THC or Grass?

"Cannabis, Hashish, Tetrahydrocannabinol (THC), and Marijuana are often prescribed to patients with obstructive hypertrophic cardiomyopathy. Additionally, these medications can be used in the treatment of communicable diseases, ethylene glycol poisoning and disinfection therapy on skin surfaces."

Answered by AI

To what extent has recruitment been successful for this clinical trial?

"Absolutely, the clinicaltrials.gov portal reveals that this medical trial is currently actively seeking participants. It was first announced on July 28th 2021 and has since been updated as recently as October 27th of last year. The research team requires 12 patients from one site for their study."

Answered by AI

Could you provide details about the current enrollment status of this clinical trial?

"Data on clinicaltrials.gov reveals that this medical trial is in the process of recruiting patients. It has been available since July 28th 2021, and was most recently updated on October 27th 2021."

Answered by AI

What purposes does this clinical trial aim to accomplish?

"The primary aim of this investigation, which will be supervised at Baseline and post-medicine administration points (10 min; 1.5 hours 2.5 hours) is to assess the impacts of marijuana and alcohol on participants' social/emotional cognition as measured by Cogstate tasks. Secondary objectives include a scrutiny into changes in THC/metabolite levels via Quantisal Oral Fluid Collection devices over 3 time periods throughout each day, an evaluation of operational control when driving using Road Tracking Task standard deviation from the lane's centre point, and finally a comparison between headway gaps chosen while overtaking stopped cars with Gap Acceptance"

Answered by AI

Are octogenarians eligible to join this experiment?

"This clinical trial is exclusively open to individuals aged between 21 and 40 in adherence with the inclusion criteria."

Answered by AI

Could you explain the outcome of any previous experiments involving cannabis derivatives?

"Presently, there are 67 live trials concerning High Marijuana, Hash, THC, or Grass. 11 of those have progressed to Phase 3 clinical studies. The majority of the experiments for this treatment take place in Lexington, Kentucky; however it is also being tested at 1010 other sites as well."

Answered by AI

Is it possible to participate in this clinical research study?

"This clinical trial seeks 12 participants with a long-term history of cannabis abuse, between 21 and 40 years old. The essential criteria for candidates include: possessing a valid driver's license; two or more years of highway driving experience; consistently using cannabis over the past 2 years, including episodes where intoxication was achieved; regular alcohol consumption along side marijuana use (though not necessarily at the same time); having used marijuana 5 times or more in their lifetime, potentially up to daily usage but also intermittent days without cravings or withdrawal symptoms."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
How old are they?
18 - 65
What site did they apply to?
Hartford Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~3 spots leftby May 2025