title: Baclofen as add-on to standard psychosocial treatment for alcohol dependence: a randomized, double-blind, placebo-controlled trial with 1 year follow-up.
abstract: BACKGROUND
  Limited clinical trials and case-reports yielded conflicting results regarding the efficacy of baclofen (a GABAB agonist) in the treatment of alcohol dependence. The aim of this study was to test the efficacy and tolerability of baclofen in alcohol dependent patients in Israel.
  
  
  METHODS
  The study was a double-blind, placebo-controlled, randomized trial comparing 50mg/day of baclofen to placebo over 12 weeks, in addition to a standard psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving, distress and depression levels; self-efficacy; social support from different sources; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
  
  
  RESULTS
  Sixty-four patients were randomized; 62% completed the 12-week trial and 37% completed the 52-week follow-up. No between group differences were found in the percentages of heavy drinking and abstinent days. A significant reduction in levels of distress, depression and craving and improved HRQL occurred for both arms, whereas self-efficacy and social support remained unchanged in both groups. No adverse events were observed.
  
  
  CONCLUSIONS
  Unlike previous positive trials in Italy, and similarly to a negative trial in the USA, we found no evidence of superiority of baclofen over placebo in the treatment of alcohol dependence. However, the high placebo response undermines the validity of this conclusion. Therefore, more placebo-controlled trials are needed to either verify or discard a possible clinical efficacy of baclofen for alcohol dependence.
authors.affiliation: Research Unit, Mental Health Services, Ministry of Health, Jerusalem, Israel. Electronic address: alexpon8@gmail.com.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Ponizovsky
authors.affiliation: Department for the Treatment of Substance Abuse, Ministry of Health, Jerusalem, Israel.
authors.forename: Paola
authors.initials: P
authors.lastname: Rosca
authors.affiliation: Computer Sciences, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Edward
authors.initials: E
authors.lastname: Aronovich
authors.affiliation: Research Unit, Geha Mental Health Center, Petah Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv,Israel.
authors.forename: Abraham
authors.initials: A
authors.lastname: Weizman
authors.affiliation: Sha'ar Menashe Mental Health Center, Bruce Rappaport Medical Faculty, Technion, Haifa, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Grinshpoon
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D001418:Baclofen / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D058786:GABA-B Receptor Agonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011613:Psychotherapy; D011788:Quality of Life; D020377:Self Efficacy; D012944:Social Support; D016896:Treatment Outcome
chemical_list: D058786:GABA-B Receptor Agonists; D001418:Baclofen
keywords: Alcohol dependence; Baclofen; Clinical trial