Gabapentin for Alcohol Relapse Prevention

Phase 2

Completed

• Conditions: Alcohol Withdrawal; Alcohol Use Disorder
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT02349477
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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").

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-29
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Results First Submitted: 2019-08-29
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Results First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	matching placebo
Gabapentin	Gabapentin	Gabapentin up to 1200 mg per day in 3 divided doses

Primary Outcome Measures

Name	Time	Method
Percent of Subjects With no Heavy Drinking Days (PSNHDD)	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.

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects With no Drinking Days (PSNDD)	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States