title: Dose-response effect of baclofen in reducing daily alcohol intake in alcohol dependence: secondary analysis of a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To explore the effect of baclofen in a dose of 20 mg three times per day, compared with the already studied dose of 10 mg three times per day, in the treatment of alcohol dependence.
  
  
  METHODS
  We present a secondary analysis of a 12-week double-blind, placebo-controlled, randomized clinical trial with two doses of baclofen, specifically 10 mg t.i.d. and 20 mg t.i.d. Out of 94 subjects consecutively screened, 42 were randomized into the study. Fourteen of the 42 patients were randomly allocated to placebo, 14 to the group treated with baclofen 10 mg t.i.d. (B10 mg) and 14 to the group treated with baclofen 20 mg t.i.d. (B20 mg).
  
  
  RESULTS
  Compared with patients allocated to placebo, patients allocated to the B10 mg group had a 53% reduction in the number of drinks per day (P < 0.0001) and patients allocated to the B20 mg group had a 68% reduction in the number of drinks per day (P < 0.0001), with respect to the number of drinks per day during the 28 days before randomization. The effect of baclofen 20 mg t.i.d. was greater than that of baclofen 10 mg t.i.d. (P = 0.0214, Wald test) showing a dose-effect relationship. Both doses of baclofen were well tolerated.
  
  
  CONCLUSIONS
  This is provisional evidence of a dose-response effect for baclofen in the treatment of alcohol dependence.
authors.affiliation: Institute of Internal Medicine, Catholic University of Rome, Largo A. Gemelli 8, I-00168 Rome, Italy. g.addolorato@rm.unicatt.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Addolorato
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Leggio
authors.forename: Anna
authors.initials: A
authors.lastname: Ferrulli
authors.forename: Silvia
authors.initials: S
authors.lastname: Cardone
authors.forename: Giorgio
authors.initials: G
authors.lastname: Bedogni
authors.forename: Fabio
authors.initials: F
authors.lastname: Caputo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gasbarrini
authors.forename: Raffaele
authors.initials: R
authors.lastname: Landolfi
mesh_terms: D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy* / Q000378:metabolism / Q000517:prevention & control; D000437:Alcoholism / Q000188:drug therapy* / Q000378:metabolism / Q000517:prevention & control; D001418:Baclofen / Q000009:adverse effects / Q000627:therapeutic use*; D002492:Central Nervous System Depressants / Q000009:adverse effects / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000431:Ethanol / Q000009:adverse effects / Q000494:pharmacology; D005260:Female; D058786:GABA-B Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002492:Central Nervous System Depressants; D058786:GABA-B Receptor Agonists; D010919:Placebos; D000431:Ethanol; D001418:Baclofen