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Gabapentin for Alcohol Relapse Prevention

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status and phase

Completed
Phase 2

Conditions

Alcohol Withdrawal
Alcohol Use Disorder

Treatments

Drug: Placebo
Drug: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT02349477
Pro00032587

Details and patient eligibility

About

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").

Full description

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.

Enrollment

96 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

96 participants in 2 patient groups, including a placebo group

Gabapentin
Experimental group
Description:
Gabapentin up to 1200 mg per day in 3 divided doses
Treatment:
Drug: Gabapentin
placebo
Placebo Comparator group
Description:
matching placebo
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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