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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-29

Study Completion Date

2013-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

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

Arm B

Group Type EXPERIMENTAL

Diphenhydramine citrate

Intervention Type DRUG

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

Arm C

Group Type ACTIVE_COMPARATOR

Triazolam

Intervention Type DRUG

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

Arm D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral, prior to bedtime on the night before performance testing

Interventions

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Gabapentin

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

Intervention Type DRUG

Diphenhydramine citrate

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

Intervention Type DRUG

Triazolam

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

Intervention Type DRUG

Placebo

Oral, prior to bedtime on the night before performance testing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes