Gabapentin for Alcohol Relapse Prevention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-08-27

Brief Summary

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This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

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Detailed Description

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This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.

Conditions

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Alcohol Use Disorder Alcohol Withdrawal

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

Gabapentin up to 1200 mg per day in 3 divided doses

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

gaba potentiating medication

placebo

matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

a pill that looks exactly like the active medication but does not contain medication

Interventions

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Gabapentin

gaba potentiating medication

Intervention Type DRUG

Placebo

a pill that looks exactly like the active medication but does not contain medication

Intervention Type DRUG

Other Intervention Names

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neurontin Sugar Pill

Eligibility Criteria

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Inclusion Criteria

1. Meets criteria for alcohol use disorder based on DSM-5 criteria
2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria

1. Significant psychiatric or medical illness
2. No other substance abuse
3. Taking other medications known to treat alcohol use disorder
4. Unstable living arrangements
5. Significant legal problems pending

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No