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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 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. The trial reports 2 study locations across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07176208
The ClinicalTrials.gov registry entry for NCT07176208 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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