title: A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.
abstract: BACKGROUND
  There is presently no approved single treatment for dual alcohol and nicotine dependencies.
  
  
  OBJECTIVE
  This pilot study investigated baclofen effects in alcoholic smokers.
  
  
  METHODS
  This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment.
  
  
  RESULTS
  Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type.
  
  
  CONCLUSIONS
  This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.
authors: Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 10 Center Drive (10CRC/15330) MSC 1108; Room 1-5429, Bethesda, MD, 20892-1108, USA, lorenzo.leggio@nih.gov.
authors: Lorenzo
authors: L
authors: Leggio
authors: William H
authors: WH
authors: Zywiak
authors: Steven M
authors: SM
authors: Edwards
authors: Jennifer W
authors: JW
authors: Tidey
authors: Robert M
authors: RM
authors: Swift
authors: George A
authors: GA
authors: Kenna
mesh_terms: D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy / Q000453:epidemiology / Q000523:psychology; D057229:Alcoholics / Q000523:psychology*; D000437:Alcoholism / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D001418:Baclofen / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012907:Smoking / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D001418:Baclofen