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Gabapentin for Abstinence Initiation in Alcohol Dependence

2014-07-23 21:08:49 | BioPortfolio

Summary

Primary Hypotheses:

1. Gabapentin will significantly reduce the symptoms of alcohol withdrawal as compared to placebo. The primary outcome measure of alcohol withdrawal will be the Clinical Institute Withdrawal Alcohol (CIWA-Ar) (Sullivan, Sykora, Schneiderman, Naranjo, & Sellers, 1989) score.

2. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method.

Secondary Hypotheses:

1. Gabapentin will be superior to placebo in reducing alcohol use as measured by secondary outcomes such as amount of drinks per day, amount of drinks per drinking day, percent days abstinent and serial measurement of gamma-glutamyl transferase (GGT) serum level.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Alcohol Dependence

Intervention

Gabapentin, Placebo

Location

Substance Treatment and Research Service (STARS)
New York
New York
United States
10019

Status

Not yet recruiting

Source

New York State Psychiatric Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:49-0400

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