What is this study of oral delta-9-THC and alcohol studying for driving performance?

This study is evaluating how different doses of oral delta-9-THC alone and combined with alcohol affect driving ability and subjective feelings in healthy adults. Researchers aim to understand impairment compared to alcohol at the legal intoxication level. The Food and Drug Administration (FDA) is leading this research to address gaps in current knowledge.

Who may be eligible for this clinical trial on cannabis and driving performance?

Adults aged 21 to 55 who are healthy occasional cannabis users with a valid driver's license and recent driving experience may be eligible. Participants must have used alcohol safely in the past year and not be daily cannabis users. Please review eligibility criteria for more details.

Is there any cost to participate in this clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel arrangements.

Actively Recruiting

Phase 1

Age: 21Years - 55Years

All Genders

Healthy Volunteers

ID07176208

Study of Oral Delta-9-THC With and Without Alcohol on Driving and Perception in Healthy Adults Aged 21 to 55

Led by Food and Drug Administration (FDA) · Updated on 2026-01-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of oral delta-9-tetrahydrocannabinol THC alone and combined with alcohol on driving performance and subjective feelings in healthy adults. This research aims to fill gaps in understanding how different doses of oral THC, especially at 10 mg and below, impact driving ability in occasional cannabis users. The study also compares these effects to alcohol impairment at the legal intoxication level of 0.08% blood alcohol concentration BAC.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Sign an approved informed consent before any study procedures
Be a healthy, non-smoking adult aged 21 to 55 years, weighing at least 50 kg with BMI 18.5 to 33.0
Have a valid U.S. driver's license and have driven at least 600 miles per year for the past 3 years
Pass a driving simulation test without motion sickness or erratic driving
Have normal or clinically acceptable medical history, labs, vital signs, ECG, and physical exam
Be an occasional cannabis user with at least one exposure in last 6 months but no daily use or recent use within 1 month
Have consumed alcohol equivalent to about 0.10% BAC safely in the past year
Have used alcohol and cannabis simultaneously at least once in the past year without significant adverse reactions
Agree to avoid alcohol, nicotine, marijuana (except study drug), hemp/CBD, and illicit drugs during the study
Test negative for SARS-CoV-2 at check-in
Females must be non-childbearing or use effective birth control; males must use effective birth control and inform partners
Agree to follow study procedures and complete the study

You will not qualify if you...

History of cannabis use disorder or psychoactive drug use in past month
Any alcohol intolerance or positive ethanol patch test
Dry mouth or salivary gland issues
Psychiatric diagnoses or family history of psychotic illness
History of seizures, epilepsy, brain injury, or recent syncope
Positive drug or alcohol tests at screening
Use of medications (other than birth control) within 14 days before check-in unless approved
Participation in other investigational drug studies recently
Nicotine product use within 6 weeks before screening
Inability to tolerate quiet study environment
Allergies or sensitivity to THC or sesame
Excessive alcohol use history or potential alcohol use disorder
Suicidal ideation or attempts history
Significant medical conditions posing safety risks
COVID-19 diagnosis or symptoms at screening
Conditions affecting drug absorption
Abnormal clinically significant lab results or vital signs
Positive tests for HIV, hepatitis B or C
Poor venous access or intolerance to blood draws
Recent significant blood loss or donation
Visual or hearing impairments preventing assessments
Any other condition that prevents study participation as judged by investigator

Research Team

Trupti Indurkar

Karrielyn Gerlach

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of Oral Delta-9-THC With and Without Alcohol on Driving and Perception in Healthy Adults Aged 21 to 55

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria