NCT04970342

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

Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim: Evaluating Sensitivity to the Effects of Cannabis and Alprazolam

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Timothy L. Brown · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Driving Behavior
• Driving Under the Influence

Interventions

Type	Name	Description
DRUG	Placebo (Lactose) Capsule	Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
DRUG	0.75 mg Alprazolam Capsule	Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
DRUG	Cannabis (6.18% THC / <0.025% CBD)	Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / \<0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
DRUG	Cannabis (0%/ THC / 0% CBD)	Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.

Timeline

• Start date: 2021-07-16
• Primary completion: 2021-08-21
• Completion: 2021-08-21
• First posted: 2021-07-21
• Last updated: 2023-07-25
• Results posted: 2023-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study