Overview

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

Status:
Completed
Trial end date:
2021-08-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Timothy L. Brown
Collaborators:
Acclaro Research Solutions, Inc.
Cognitive Research Corporation
National Highway Traffic Safety Administration (NHTSA)
Treatments:
Alprazolam