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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

GabapentinDRUG

250 mg, oral, prior to bedtime on the night before performance testing

Diphenhydramine citrateDRUG

76 mg, oral, prior to bedtime on the night before performance testing

TriazolamDRUG

0.5 mg, oral, prior to bedtime on the night before performance testing

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Baptist Sleep Centers, LLP

South Miami, Florida, United States

Miami Research Associates

South Miami, Florida, United States

NeuroTrials Research Sleep Lab

Atlanta, Georgia, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Standard Deviation of Lateral Position (SDLP)

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.

Time frame: 7.25 hours post-dose

Secondary Outcomes

Speed Deviation

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.

Time frame: 7.25 hours post dose

Lane Exceedance

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.

Time frame: 7.25 hours post-dose

Data from ClinicalTrials.gov

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