NCT02404688View on ClinicalTrials.gov

Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 31, 2015

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 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.

Trial Locations (1)

06516

Biological Studies Unit, VA Connecticut Healthcare System, West Haven

All Listed Sponsors
lead

Yale University

OTHER