title: Gabapentin treatment for alcohol dependence: a randomized clinical trial.
abstract: OBJECTIVE
  Approved medications for alcohol dependence are prescribed for less than 9% of US alcoholics.
  
  
  OBJECTIVE
  To determine if gabapentin, a widely prescribed generic calcium channel/γ-aminobutyric acid-modulating medication, increases rates of sustained abstinence and no heavy drinking and decreases alcohol-related insomnia, dysphoria, and craving, in a dose-dependent manner.
  
  
  METHODS
  A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women older than 18 years with current alcohol dependence, conducted from 2004 through 2010 at a single-site, outpatient clinical research facility adjoining a general medical hospital.
  
  
  METHODS
  Oral gabapentin (dosages of 0 [placebo], 900 mg, or 1800 mg/d) and concomitant manual-guided counseling.
  
  
  METHODS
  Rates of complete abstinence and no heavy drinking (coprimary) and changes in mood, sleep, and craving (secondary) over the 12-week study. RESULTS Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1%-13.7%) in the placebo group, 11.1% (95% CI, 5.2%-22.2%) in the 900-mg group, and 17.0% (95% CI, 8.9%-30.1%) in the 1800-mg group (P = .04 for linear dose effect; number needed to treat [NNT] = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6%-37.2%) in the placebo group, 29.6% (95% CI, 19.1%-42.8%) in the 900-mg group, and 44.7% (95% CI, 31.4%-58.8%) in the 1800-mg group (P = .02 for linear dose effect; NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F2 = 7.37; P = .001), sleep (F2 = 136; P < .001), and craving (F2 = 3.56; P = .03). There were no serious drug-related adverse events, and terminations owing to adverse events (9 of 150 participants), time in the study (mean [SD], 9.1 [3.8] weeks), and rate of study completion (85 of 150 participants) did not differ among groups.
  
  
  CONCLUSIONS
  Gabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia, dysphoria, and craving, with a favorable safety profile. Increased implementation of pharmacological treatment of alcohol dependence in primary care may be a major benefit of gabapentin as a treatment option for alcohol dependence.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00391716.
authors.affiliation: The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Mason
authors.affiliation: The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.
authors.forename: Susan
authors.initials: S
authors.lastname: Quello
authors.affiliation: The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.
authors.forename: Vivian
authors.initials: V
authors.lastname: Goodell
authors.affiliation: Scripps Clinic and Scripps Green Hospital, La Jolla, California.
authors.forename: Farhad
authors.initials: F
authors.lastname: Shadan
authors.affiliation: Scripps Clinic and Scripps Green Hospital, La Jolla, California.
authors.forename: Mark
authors.initials: M
authors.lastname: Kyle
authors.affiliation: Scripps Clinic and Scripps Green Hospital, La Jolla, California.
authors.forename: Adnan
authors.initials: A
authors.lastname: Begovic
mesh_terms: D000328:Adult; D064829:Alcohol Abstinence; D000437:Alcoholism / Q000188:drug therapy*; D000588:Amines / Q000627:therapeutic use*; D002492:Central Nervous System Depressants / Q000009:adverse effects; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004311:Double-Blind Method; D000431:Ethanol / Q000009:adverse effects; D005260:Female; D018757:GABA Modulators / Q000627:therapeutic use*; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D013375:Substance Withdrawal Syndrome / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D002492:Central Nervous System Depressants; D003509:Cyclohexanecarboxylic Acids; D018757:GABA Modulators; D000431:Ethanol; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin