Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

NCT02404688 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-29

No results posted yet for this study

Summary

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Conditions

  • Cannabis
  • Alcohol Effect
  • Driving Under the Influence of Alcohol and Other Drugs

Interventions

DRUG

Active delta-9-THC

Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint". Administered over 20 minutes.

DRUG

Placebo

Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.

DRUG

Active Ethanol

Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.

DRUG

Placebo

Control: no alcohol, administered for a total of 80 minutes.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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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 NCT02404688 on ClinicalTrials.gov