Actively Recruiting
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
Led by Food and Drug Administration (FDA) · Updated on 2026-01-16
48
Participants Needed
2
Research Sites
15 weeks
Total Duration
On this page
Sponsors
F
Food and Drug Administration (FDA)
Lead Sponsor
S
Spaulding Clinical Research LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Adult men or women aged 21 to 55 years inclusive
- Healthy, non-smoking individuals weighing at least 50 kg with BMI between 18.5 and 33.0 kg/m2
- Possession of a valid U.S. driver's license and having driven a minimum of 600 miles per year for the past 3 years
- No motion sickness or erratic driving during screening driving simulation test
- Normal medical history, clinical labs, vital signs, ECG, and physical exams or clinically insignificant abnormalities
- Occasional cannabis use: at least one exposure within last 6 months, no daily use, and no use within past month
- Alcohol consumption within past year equivalent to approximately 0.10% BAC without significant adverse reactions
- At least one instance of simultaneous alcohol and cannabis use in past year without significant adverse reactions
- Agreement to avoid alcohol, nicotine, marijuana (except study drug), hemp, CBD, and illicit drugs during study
- Negative rapid antigen test for SARS-CoV-2 at check-in
- Female participants must be non-childbearing or use two effective birth control methods if childbearing potential
- Male participants must use two effective birth control methods and inform partners
- Willingness and likelihood to comply with study procedures and completion
You will not qualify if you...
- History of cannabis use disorder or psychoactive drug use in last month
- History or intolerance to alcohol
- Dry mouth or salivary gland dysfunction or surgery
- History of psychiatric disorders including mood, anxiety, or psychotic disorders
- Family history of schizophrenia or psychotic illness
- History of seizures, epilepsy, or traumatic brain injury
- Syncope within 3 months or recurrent unexplained syncope
- Positive drug or alcohol test at screening or check-in
- Use of medications other than birth control within 14 days before check-in unless approved
- Participation in another investigational drug study within 30 days or 5 half-lives
- Nicotine product use within 6 weeks before screening
- Inability to tolerate a quiet study environment without stimulating activities
- Known allergies to delta-9-THC or sesame seeds/oil
- Excessive alcohol use history or alcohol use disorder within 2 years
- Positive test for potential active alcohol use disorder
- History of suicidal ideation or attempts
- Clinically significant disorders that pose safety risks or interfere with study
- Diagnosis or symptoms of COVID-19 at screening or check-in
- Conditions affecting drug absorption such as gastrectomy or Crohn's disease
- Clinically significant abnormal lab results
- Blood pressure outside specified ranges unless clinically insignificant
- Positive tests for HIV, hepatitis B or C
- Poor venous access or unwillingness for blood draws
- Recent significant blood loss or donations
- Visual or hearing impairment affecting assessments
- Any other condition preventing participation as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Actively Recruiting
2
Spaulding Clinical
West Bend, Wisconsin, United States, 53095
Actively Recruiting
Research Team
T
Trupti Indurkar
CONTACT
K
Karrielyn Gerlach
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
6
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