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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

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Apr 14, 2026 to Jun 19, 2026
    • Eligibility criteria expanded, about 93 words
    • Secondary endpoints: details revised at 9 of 12 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 14 of 15 entries
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 22, 2025 to Dec 29, 2025
    • Study sites: 1 to 2
    • Primary and study completion dates: Feb 27, 2026 to Apr 14, 2026
    • Interventions: Alcohol beverage (Drug), Dronabinol (Marinol®) (Drug), Dronabinol (Marinol®) (Drug), Dronabinol (Marinol®) + Alcohol (Drug), Dronabinol… to 10 mg Dronabinol (Marinol®) + Alcohol Beverage (Drug), 10 mg Dronabinol (Marinol®) + Placebo Beverage (Drug), 5 mg Dronabinol (Marinol®) +…
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07176208
Lead Sponsor Food and Drug Administration (FDA)
Collaborators: Spaulding Clinical Research LLC
Conditions
(from sponsor)		 Cannabis, Drug Effects, Driving Performance
Related terms Marijuana Abuse
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov