CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Placebo (Lactose) Capsule +3 moredrug
Likely dose
0.75 mg Alprazolam Capsulefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04970342
NCT04970342Phase 1Completed
CompareCT.gov

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

Timothy L. Brown·interventional·Posted Jul 21, 2021·Updated Jul 25, 2023

In Brief

A Phase 1 clinical trial evaluating Placebo (Lactose) Capsule, 0.75 mg Alprazolam Capsule, and 2 other interventions for Driving Behavior and Driving Under the Influence. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDriving Behavior, Driving Under the Influence
CountriesUnited States
CollaboratorsNational Highway Traffic Safety Administration (NHTSA), Acclaro Research Solutions, Inc., Cognitive Research Corporation

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 21, 2021
Enrollment StartJul 16, 2021
Primary CompletionAug 21, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.9 years ago

Interventions

Placebo (Lactose) Capsuledrug

Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose

0.75 mg Alprazolam Capsuledrug

Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose

Cannabis (6.18% THC / <0.025% CBD)drug

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.

Cannabis (0%/ THC / 0% CBD)drug

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.