Examine the Feasibility of a Standardized Field Test for Marijuana and Alcohol Impairment: Laboratory Evaluations

NCT04856566 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Marijuana Impairment
  • Alcohol Impairment

Interventions

DRUG

Low Marijuana, Hash, THC, or Grass

Cannabis with low amount of THC

DRUG

High Marijuana, Hash, THC, or Grass

Cannabis with high amount of THC

DRUG

Placebo

Placebo drug with no THC

DRUG

0.05 BAC Alcohol

Amount of alcohol when consumed leads to BAC of 0.05

DRUG

0.08 BAC Alcohol

Amount of alcohol when consumed leads to BAC of 0.08

Sponsors & Collaborators

  • National Highway Traffic Safety Administration (NHTSA)

    collaborator FED
  • Hartford Hospital

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Godfrey Pearlson, M.D · Founding Director, Olin Neuropsychiatry Center; Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-08-23
Completion
2023-08-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856566 on ClinicalTrials.gov