drugset
drugset / Trial / NCT04970342

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

NCT04970342 ↗

Phase 1 Completed 13 enrolled Timothy L. Brown Acclaro Research Solutions, Inc. · collabCognitive Research Corporation · collabNational Highway Traffic Safety Administration (NHTSA) · collab
RandomizedCrossoverTriple-blindBasic science

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.

Timeline

Start
2021-07-16
Primary completion
2021-08-21
Completion
2021-08-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Alprazolam Small molecule 0.75 mg Oral
Subject Cannabis Traditional medicine (herbal / TCM) 500 mg Inhaled

Indications

No indication recorded.