Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: Diphenhydramine citrate; Drug: Triazolam; Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT01888497
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Study Start: 2013-07-29
• Primary Completion: 2013-12-14
• Study Completion: 2013-12-14
• Disposition First Submitted: 2014-12-15
• Disposition First Submitted QC: 2014-12-15
• Disposition First Posted: 2015-01-06
• Results First Submitted: 2020-11-12
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-19
• Results First Posted: 2021-02-05
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Healthy males and females of non-childbearing potential, 25-55 years of age
• Valid driver's license

Exclusion Criteria

• Psychiatric disorder
• Recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma
• Recent histroy or current treatment for sleep disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm B	Diphenhydramine citrate	-
Arm C	Triazolam	-
Arm D	Placebo	-
Arm A	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Standard Deviation of Lateral Position (SDLP)	7.25 hours post-dose	Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive.

Secondary Outcome Measures

Name	Time	Method
Lane Exceedance	7.25 hours post-dose	Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Mean lanes excursed/exceeded was reported in the outcome measure.
Speed Deviation	7.25 hours post dose	Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Standard deviation of speed was reported in the outcome measure.

Trial Locations

Locations (4)

NeuroTrials Research, Inc.; 🇺🇸 Atlanta, Georgia, United States

NeuroTrials Research Sleep Lab; 🇺🇸 Atlanta, Georgia, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Baptist Sleep Centers, LLP; 🇺🇸 South Miami, Florida, United States