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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

February 27, 2026

Study Completion Date

February 27, 2026

Conditions
Cannabis, Drug EffectsDriving Performance
Interventions
DRUG

Dronabinol (Marinol®)

Subjects in this arm will receive one dose of 5 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.

DRUG

Dronabinol (Marinol®)

Subjects in this arm will receive one dose of 10 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.

DRUG

Dronabinol (Marinol®) + Alcohol

Subjects in this arm will receive one dose of 5 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

DRUG

Dronabinol (Marinol®) + Alcohol

Subjects in this arm will receive one dose of 10 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

DRUG

Alcohol beverage

Subjects in this arm will receive placebo capsule with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

DRUG

Placebo

Subjects in this arm will receive a placebo capsule with a placebo beverage in one of the assigned treatment days.

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

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 | Biotech Hunter | Biotech Hunter