Overview

Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (9-THC) With and Without Alcohol on Perception and Driving Performance in Healthy Adults

Status:
NOT_YET_RECRUITING

Trial end date:
2026-02-27

Target enrollment:

Participant gender:

Summary

With the increasing prevalence and use of cannabis products by the public, there exists a need to better understand the safety impact of cannabis use, particularly when it comes to subjective perceptions of drug effect and driving impairment. This study aims to evaluate the dose-dependent effects of oral 9-THC alone and in combination with alcohol (0.08% BAC \[Blood Alcohol Concentration\]) on driving performance and subjective feeling in healthy adults. The results of this study will address current knowledge gaps on the effects of oral 9-THC on driving impairment across a clinically relevant dose range.

Phase:

PHASE1

Details

Lead Sponsor:

Food and Drug Administration (FDA)

Collaborator:

Spaulding Clinical Research LLC

Treatments:

Dronabinol
Ethanol