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

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.

Conditions

• Driving Behavior
• Driving Under the Influence

Interventions

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.

Sponsors & Collaborators

• National Highway Traffic Safety Administration (NHTSA)

  collaborator FED

• Acclaro Research Solutions, Inc.

  collaborator INDUSTRY

• Cognitive Research Corporation

  collaborator INDUSTRY

• Timothy L. Brown

  lead OTHER

Principal Investigators

• Timothy L Brown · National Advanced Driving Simulator, University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-16

Primary Completion

2021-08-21

Completion

2021-08-21

FDA Drug

Yes

Countries

• United States

Study Locations