Gabapentin Treatment of Alcohol Dependence

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Alcoholism; Alcohol Dependence

Treatments: Drug: placebo; Behavioral: behavioral counseling; Drug: Gabapentin 900mg; Drug: gabapentin 1800mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00391716

R37AA014028 (U.S. NIH Grant/Contract)

NIAAAMAS014028

Details and patient eligibility

About

Gabapentin treatment for alcohol dependence

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

gabapentin 900mg daily

Experimental group

Description:

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

Treatment:

Drug: Gabapentin 900mg

Behavioral: behavioral counseling

gabapentin 1800mg daily

Experimental group

Description:

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

Treatment:

Drug: gabapentin 1800mg

Behavioral: behavioral counseling

placebo daily

Placebo Comparator group

Description:

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

Treatment:

Behavioral: behavioral counseling

Drug: placebo