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NCT07176208 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Driving Performance and Cannabis, Drug Effects, sponsored by Food and Drug Administration (FDA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT07176208: Recruiting Phase 1 study of Driving Performance and Cannabis, Drug Effects, sponsored by Food and Drug Administration (FDA).
NCT07176208 is a Phase 1 study of Driving Performance and Cannabis, Drug Effects that is actively recruiting participants, run by Food and Drug Administration (FDA). The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07176208, a Phase 1 study of Driving Performance and Cannabis, Drug Effects, is actively recruiting participants, sponsored by Food and Drug Administration (FDA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG 5 mg Dronabinol (Marinol®) + Placebo Beverage
- DRUG 10 mg Dronabinol (Marinol®) + Placebo Beverage
- DRUG 5 mg Dronabinol (Marinol®) + Alcohol Beverage
- DRUG 10 mg Dronabinol (Marinol®) + Alcohol Beverage
- DRUG Placebo Capsule + Alcohol Beverage
Study Locations (2)
Wisconsin
- Spaulding Clinical Research - West Bend
- Spaulding Clinical - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-12-29 |
| Est. Completion | 2026-04-14 |
| Phase | Phase 1 |
What NCT07176208 shows while recruiting
NCT07176208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Driving Performance appearing as the primary indexed condition, and to 5 interventions - of which 5 mg Dronabinol (Marinol®) + Placebo Beverage is the first listed.
NCT07176208 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT07176208 about?
NCT07176208 is a clinical study titled "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". 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...
What is the current status of trial NCT07176208?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-12-29. Estimated completion is 2026-04-14.
What conditions does trial NCT07176208 study?
This clinical trial studies the following conditions: Driving Performance, Cannabis, Drug Effects.
What interventions are being tested in trial NCT07176208?
The interventions under investigation include: 5 mg Dronabinol (Marinol®) + Placebo Beverage (DRUG), 10 mg Dronabinol (Marinol®) + Placebo Beverage (DRUG), 5 mg Dronabinol (Marinol®) + Alcohol Beverage (DRUG), 10 mg Dronabinol (Marinol®) + Alcohol Beverage (DRUG), Placebo Capsule + Alcohol Beverage (DRUG).
Who is sponsoring clinical trial NCT07176208?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07176208 being conducted?
This trial has 2 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07176208's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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