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Completed

NCT Number: NCT02349477

Gabapentin for Alcohol Relapse Prevention

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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Key information

Conditions

Alcohol Use Disorder Alcohol Withdrawal Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Significant psychiatric or medical illness
  • No other substance abuse
  • Taking other medications known to treat alcohol use disorder
  • Unstable living arrangements
  • Significant legal problems pending

Treatment and study plan

Gabapentin

Drug

gaba potentiating medication

Other names: neurontin

Placebo

Drug

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

Other names: Sugar Pill

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2015
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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