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

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 delta-9-THC

"Low dose THC (\~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer."

DRUG

Placebo

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

DRUG

Placebo

Control: No active THC. Administered over 20 minutes via a vaporizer. 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 consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.

Trial Locations (1)

06516

Biological Studies Unit, VA Connecticut Healthcare System, West Haven

All Listed Sponsors
lead

Yale University

OTHER