A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-08-31

Brief Summary

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The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

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Detailed Description

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Conditions

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Transient Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

B

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo oral capsule 30 minutes prior to bedtime

Interventions

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Gabapentin

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

Intervention Type DRUG

Gabapentin

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime

Intervention Type DRUG

Placebo

Matched placebo oral capsule 30 minutes prior to bedtime

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged \>/= 18 years who reported occasional sleeplessness in the month prior to screening
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No