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Study on Oral THC and Alcohol Effects on Driving

This study is looking at how different doses of oral delta-9-tetrahydrocannabinol (Δ9-THC), given as Dronabinol (Marinol®), affect driving performance and how people feel, both alone and when combined with alcohol. Researchers want to understand the safety of cannabis use, especially when driving, and how it compares to the effects of alcohol alone. You might be able to join if you are a healthy adult between 21 and 55 years old. The study will measure driving performance using a simulated driving test to see if Dronabinol (Marinol®) alone or with alcohol affects it differently than alcohol alone. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 48 healthy adults. Participants will receive different combinations of Dronabinol (Marinol®) and/or an alcoholic beverage on assigned treatment days.
What's involved
Participants will receive one dose of Dronabinol (Marinol®) or a placebo capsule, sometimes with an alcoholic beverage, on assigned treatment days. Driving performance will be measured for up to 8 hours after taking the study drug.
Compensation
Not stated in the trial record.
Follow-up
Driving performance will be measured for up to 8 hours after study drug administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07176208

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
PHASE1Ages 21–55Interventional
Food and Drug Administration (FDA)
~48 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:5 mg Dronabinol (Marinol®) + Placebo Beverage10 mg Dronabinol (Marinol®) + Placebo Beverage5 mg Dronabinol (Marinol®) + Alcohol Beverage10 mg Dronabinol (Marinol®) + Alcohol BeveragePlacebo Capsule + Alcohol BeveragePlacebo Capsule + Placebo Beverage

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.
Measured over Up to 8 hours after study drug administration.

Conditions

Cannabis, Drug Effects
Driving Performance

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Healthy Volunteers

NCT07176208

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Spaulding Clinical

    West Bend, Wisconsinstudy coordinator listed

    Recruiting

  • Spaulding Clinical Research

    West Bend, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melanie Fein, MD · PRINCIPAL_INVESTIGATOR · Spaulding Clinical Research LLC

Who to contact

Trupti Indurkar
[email protected]
3475740355
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.Up to 8 hours after study drug administration.

    Simulated driving performance will be measured by the endpoint standard deviation of lateral position (SDLP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to active control (alcohol alone).