A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

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

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with 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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Gabapentin

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo 30 minutes prior to bedtime for 28 days

Interventions

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Placebo

Matched placebo 30 minutes prior to bedtime for 28 days

Intervention Type DRUG

Gabapentin

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older with occasional sleeplessness in the month prior to screening

Exclusion Criteria

* Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep
* Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No