Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
CannabisAlcohol EffectDriving Under the Influence of Alcohol and Other Drugs
Interventions
DRUG

Active inhaled cannabis

"\~450 mg of active cannabis, which is roughly equivalent to smoking 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer."

DRUG

Placebo

Approximately 4 drinks of orange juice or ginger ale covered with a trace amount of ethanol on the surface, each administered over approximately 10 minutes.

DRUG

Active Oral Ethanol

0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

DRUG

Placebo

No active cannabinoids. Administered over 20 minutes via a vaporizer.

Trial Locations (1)

06516

Biological Studies Unit, VA Connecticut Healthcare System, West Haven

All Listed Sponsors
lead

Yale University

OTHER