NCT02709954

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

To study the effects of oral ethanol (a target BAC of \~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2016-03-16
• Last updated: 2025-04-15

Locations

1 site across 1 country: United States