Gabapentin Treatment of Alcohol Dependence

NCT ID: NCT00391716

Last Updated: 2014-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2010-02-28

Brief Summary

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Gabapentin treatment for alcohol dependence

Detailed Description

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This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Conditions

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Alcoholism Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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gabapentin 900mg daily

900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Group Type EXPERIMENTAL

Gabapentin 900mg

Intervention Type DRUG

900 mg gabapentin daily for 12 weeks

behavioral counseling

Intervention Type BEHAVIORAL

The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

gabapentin 1800mg daily

1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks

Group Type EXPERIMENTAL

behavioral counseling

Intervention Type BEHAVIORAL

The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

gabapentin 1800mg

Intervention Type DRUG

1800 mg gabapentin daily for 12 weeks

placebo daily

placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Group Type PLACEBO_COMPARATOR

behavioral counseling

Intervention Type BEHAVIORAL

The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

placebo

Intervention Type DRUG

lactose capsule compounded to mimic gabapentin capsules

Interventions

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Gabapentin 900mg

900 mg gabapentin daily for 12 weeks

Intervention Type DRUG

behavioral counseling

The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

Intervention Type BEHAVIORAL

placebo

lactose capsule compounded to mimic gabapentin capsules

Intervention Type DRUG

gabapentin 1800mg

1800 mg gabapentin daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Neurontin alcoholfree.info lactose capsule Neurontin

Eligibility Criteria

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Inclusion Criteria

* Men and women over age 18 with alcohol dependence

Exclusion Criteria

* Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

The Scripps Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Barbara J. Mason

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara J. Mason, PhD

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

Locations

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The Scripps Research Institute

La Jolla, California, United States

Site Status

Countries

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United States

References

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Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.

Reference Type RESULT
PMID: 24190578 (View on PubMed)

Other Identifiers

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R37AA014028

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAMAS014028

Identifier Type: -

Identifier Source: org_study_id