Gabapentin Combined With Naltrexone for the Treatment of Alcohol Dependence

Am J Psychiatry. 2011 Jul;168(7):709-17. doi: 10.1176/appi.ajp.2011.10101436. Epub 2011 Mar 31.

Abstract

Objective: Naltrexone, an efficacious medication for alcohol dependence, does not work for everyone. Symptoms such as insomnia and mood instability that are most evident during early abstinence might respond better to a different pharmacotherapy. Gabapentin may reduce these symptoms and help prevent early relapse. This clinical trial evaluated whether the combination of naltrexone and gabapentin was better than naltrexone alone and/or placebo during the early drinking cessation phase (first 6 weeks), and if so, whether this effect persisted.

Method: A total of 150 alcohol-dependent individuals were randomly assigned to a 16-week course of naltrexone alone (50 mg/day [N=50]), naltrexone (50 mg/day) with gabapentin (up to 1,200 mg/day [N=50]) added for the first 6 weeks, or double placebo (N=50). All participants received medical management.

Results: During the first 6 weeks, the naltrexone-gabapentin group had a longer interval to heavy drinking than the naltrexone-alone group, which had an interval similar to that of the placebo group; had fewer heavy drinking days than the naltrexone-alone group, which in turn had more than the placebo group; and had fewer drinks per drinking day than the naltrexone-alone group and the placebo group. These differences faded over the remaining weeks of the study. Poor sleep was associated with more drinking in the naltrexone-alone group but not in the naltrexone-gabapentin group, while a history of alcohol withdrawal was associated with better response in the naltrexone-gabapentin group.

Conclusions: The addition of gabapentin to naltrexone improved drinking outcomes over naltrexone alone during the first 6 weeks after cessation of drinking. This effect did not endure after gabapentin was discontinued.

Trial registration: ClinicalTrials.gov NCT00183196.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Alcohol Drinking / psychology
  • Alcoholism / drug therapy*
  • Alcoholism / psychology
  • Amines / therapeutic use*
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Gabapentin
  • Humans
  • Male
  • Middle Aged
  • Naltrexone / administration & dosage
  • Naltrexone / therapeutic use*
  • Narcotic Antagonists / therapeutic use*
  • Secondary Prevention
  • Substance Withdrawal Syndrome / prevention & control
  • Treatment Outcome
  • gamma-Aminobutyric Acid / therapeutic use*

Substances

  • Amines
  • Cyclohexanecarboxylic Acids
  • Narcotic Antagonists
  • gamma-Aminobutyric Acid
  • Naltrexone
  • Gabapentin

Associated data

  • ClinicalTrials.gov/NCT00183196