NCT02710331

Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

• 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 ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.

Conditions

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

Interventions

Type	Name	Description
DRUG	Active Dronabinol	10 mg capsule of Dronabinol will be administered orally.
DRUG	Placebo	Control: no alcohol, administered for \~80 minutes.
DRUG	Placebo	Control: Placebo pill (no active cannabinoids) administered orally.
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2016-03-16
• Last updated: 2025-04-09

Locations

1 site across 1 country: United States