Cannabis Consumption and Driving Impairment Assessment on a Closed Course (NCT06059677) | Clinical Trial Compass
UnknownPhase 2
Cannabis Consumption and Driving Impairment Assessment on a Closed Course
United States300 participantsStarted 2023-10-03
Plain-language summary
In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Possessing a valid California driver's license
* Cannabis use in the past six months
* Willing and able to abstain from alcohol, cannabis, and other recreational drugs for 24 hours prior to scheduled participation
* Willing and able to avoid driving and operating heavy machinery for at least four hours after participation
* Residence within approximately 15 miles of the study site
* Possessing the capacity to provide informed consent
Exclusion Criteria:
* Completion of a roadside sobriety test during the previous 12 months
* Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated
* Potential presence of Cannabis Use Disorder as assessed by a modified version of the Cannabis Use Disorder Identification Test
* Potential presence of Substance Use Disorder as assessed by a modified version of the Drug Abuse Screening Test
* Pregnancy or breastfeeding reported
* Unwillingness to be transported by taxi
* Having been convicted of Driving Under the Influence (DUI) within five years prior to scheduled participation
* Parole or probation status
* One or more felony convictions on record involving aggressive or dangerous criminal activity
* Any of the following at the time of the experimental session: breath alcohol content of .01% or greater; positive pregnancy test; cannabis consumption considered unsafe following medical checkup by the study nurse; or driving test behavior considered hazardous…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Driving Performance Examination (MDPE)
Timeframe: Conducted an average of 35 minutes after the assigned intervention is completed.