Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim (NCT04970342) | Clinical Trial Compass
CompletedPhase 1
Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim
United States13 participantsStarted 2021-07-16
Plain-language summary
Subjects will participate in a 4-visit study protocol at the National Advanced Driving Simulator, part of the University of Iowa, in which they will be asked to complete assorted questionnaires, computerized cognitive tasks, and a simulator drive. Subjects will be administered 0.75 mg alprazolam (Xanax) or placebo and 500 mg vaporized cannabis (6.18% THC / \<0.025% CBD) or placebo (0% THC / 0% CBD).
The primary objective of this study is to validate the Drug Impaired Driving Scenario (DIDS) using the CRCDS-2 driving simulator by assessing the acute effects of cannabis relative to placebo on simulated driving performance. Assay sensitivity will be demonstrated by the significant effect of 0.75 mg alprazolam (active comparator) on driving and cognitive endpoints.
Who can participate
Age range
19 Years – 45 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:
* Understands and provides written informed consent prior to the initiation of any protocol-specific procedures.
* Able to comprehend and willing to comply with the requirements of the protocol.
* Healthy male or female adult, 19 to 45 years of age, inclusive, at Screening.
* Regular sleep pattern (usual bedtime between 21:00 and 00:00).
* Score \<10 on Epworth Sleepiness Scale at Screening.
* Able to reliably perform study assessments at Screening (On practice scenario, SDLP no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario and subject has 7 or more correct hits on the Divided Attention task; CogScreen SDC Correct no less than 1 standard deviation below the mean for healthy adults); demonstrates the ability to understand task instructions at Screening; and is physically (e.g., adequate manual dexterity, vision, and hearing) and cognitively capable of performing study tasks at Screening.
* Possesses (and is willing to provide) a valid driver's license and is an active driver.
* Determined to be (by self-report) an active cannabis user with use of at least once per month over the preceding 90 days.
* Willing to abstain from cannabis use (other than study drug) beginning at the end of Screening until discharge from NADS on Day 2 of Treatment Period 3.
* Female subjects must meet one of the following criteria: 1) If of childbearing potential, female subjects agree to use two contraceptive reg…
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
Standard Deviation of Lateral Position (SDLP)
Timeframe: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3