Validation of the Drug Impaired Driving Scenario (DIDS) on

Status Completed

Clinical Trial 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.

Clinical Trial Description

At the University of Iowa's National Advanced Driving Simulator (NADS), normal healthy subjects who currently use cannabis recreationally (at least once a month) will be recruited. The study involves four visits, the first of which is a screening visit of approximately 3 hours. At the screening visit, consent is obtained, questionnaires are given, and a physical and psychological exam is administered. Subjects will also train on study procedures, such as the cognitive testing, the simulator drive, and the cannabis inhalation procedure. Subjects will then be scheduled for their three treatment visits, which will be one week apart.. The treatment visits will have a clean (double placebo) and two treatment visits (active alprazolam and placebo cannabis, placebo alprazolam and active cannabis). The alprazolam dose is 0.75 mg and the cannabis dose is 500 mg. All cannabis will be inhaled via a Volcano® Digit vaporizer using the Foltin Puff Procedure. Each of the treatment visits will last approximately twenty-three hours and will include intake with eligibility and baseline testing, transport to a local hotel, an overnight stay at the hotel, transport to NADS, being dosed with study drugs or placebos, cognitive assessments, a simulator drive, and assorted questionnaires. There will also be 8 mL blood sampling before dosing, before driving, and after driving. Each randomized subject will complete a treatment visit of each type one week apart in a counterbalanced sequence. Meals will be provided at the treatment visits (dinner, snack, breakfast, lunch). Subjects will be monitored until the drug effects have subsided sufficiently to ensure it is safe to transport them home. Subjects will need to arrange their own transportation; they will not be permitted to drive themselves home after the treatment visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04970342
Study type	Interventional
Source	University of Iowa
Contact
Status	Completed
Phase	Phase 1
Start date	July 16, 2021
Completion date	August 21, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim — PDID

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms