Clinical Trial

Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (Δ9-THC) With and Without Alcohol on Perception and Driving Performance in Healthy Adults

Recruiting Phase 1

Record status

This record was last updated January 16, 2026 (before its estimated April 14, 2026 completion). Its status may not reflect the trial's current state.

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 Δ9-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 Δ9-THC on driving impairment across a clinically relevant dose range.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-09-08.

Status change: Not Yet Recruiting → Recruiting 2026-01-14

Trial Details

NCT Number	NCT07176208
Lead Sponsor	Food and Drug Administration (FDA) Collaborators: Spaulding Clinical Research LLC
Conditions	Cannabis, Drug Effects, Driving Performance
Enrollment	48 participants
Start Date	2025-12-29
Primary Completion	2026-04-14 (estimated)
Study Completion	2026-04-14 (estimated)
Updated on ClinicalTrials.gov	2026-01-16