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

Conditions

• Cannabis, Drug Effects
• Driving Performance

Eligibility Criteria

Sex

ALL

Age

21 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• 5 mg Dronabinol (Marinol®) + Placebo Beverage — DRUG
  Subjects in this arm will receive one dose of 5 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.
• 10 mg Dronabinol (Marinol®) + Placebo Beverage — DRUG
  Subjects in this arm will receive one dose of 10 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.
• 5 mg Dronabinol (Marinol®) + Alcohol Beverage — DRUG
  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.
• 10 mg Dronabinol (Marinol®) + Alcohol Beverage — DRUG
  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.
• Placebo Capsule + Alcohol Beverage — DRUG
  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.
• Placebo Capsule + Placebo Beverage — DRUG
  Subjects in this arm will receive a placebo capsule with a placebo beverage in one of the assigned treatment days.

Study Details

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.

Key Dates

Start date

Dec 29, 2025

Status verified

Jan 2026

Primary completion

Apr 14, 2026

Completion

Apr 14, 2026

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Experimental: Treatment A - 5 mg Δ9-THC + Placebo beverage
  Subjects in this arm will receive one 5 mg oral dose of THC and a placebo beverage
• Experimental: Treatment B - 10 mg Δ9-THC + Placebo beverage
  Subjects in this arm will receive one 10 mg oral dose of THC and a placebo beverage
• Experimental: Treatment C - 5 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%
  Subjects in this arm will receive one 5 mg oral dose of THC and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08%
• Experimental: Treatment D - 10 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%
  Subjects in this arm will receive one 10 mg oral dose of THC and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08%
• Active Comparator: Treatment E - Placebo capsule + Alcohol beverage with BAC target of 0.08%
  Subjects in this arm will receive one placebo capsule and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08% as a positive control
• Placebo Comparator: Treatment F - Placebo capsule + Placebo beverage
  Subjects in this arm will receive one placebo capsule and a placebo beverage

Primary Outcome Measure

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. [ Time Frame: Up to 8 hours after study drug administration. ]

Central Contacts

• Trupti Indurkar
  3475740355
  [email protected]
• Karrielyn Gerlach
  9205172167
  [email protected]

Locations (2)

Find similar trials in West Bend, WI

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• The Effects of Cannabidiol on the Driving Performance of Healthy Adults by Dose and Sex
  PHASE1 · Recruiting · West Virginia University · Morgantown, West Virginia