Gabapentin for Alcohol Relapse Prevention

October 15, 2019 updated by: Medical University of South Carolina

Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects

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").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
matching placebo
Drug: Placebo
a pill that looks exactly like the active medication but does not contain medication
Other Names:
  • Sugar Pill
Experimental: Gabapentin
Gabapentin up to 1200 mg per day in 3 divided doses
Drug: Gabapentin
gaba potentiating medication
Other Names:
  • neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
Time Frame: 4 months
The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects With no Drinking Days (PSNDD)
Time Frame: 4 months
The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT.
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With No Drinking Days by AWS Score and Medication
Time Frame: 4 months
This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome).
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Raymond F Anton, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 27, 2018

Study Completion (Actual)

August 27, 2018

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 23, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00032587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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