title: Results from a pilot clinical trial of varenicline for the treatment of alcohol dependence.
abstract: BACKGROUND
  Alcohol use, abuse and dependence remain a pressing public health problem. Based on its mechanism of action, varenicline seemed to be a likely candidate for treating alcohol dependence.
  
  
  METHODS
  Alcohol dependent subjects (n=40) were enrolled in a 13-week double-blind placebo controlled clinical trial. Subject visits were once per week. At each visit, subjects were tested for breath alcohol levels, provided self-report data on alcohol and nicotine use, and on mood and craving. In addition, subjects received once a week medical management (MM).
  
  
  RESULTS
  There was no difference between varenicline and placebo treated groups on any of the drinking outcomes. Compared to placebo-treated subjects, varenicline treated subjects had decreased rates of alcohol craving and cigarette smoking, as well as greater mood improvements during the later part of the study (weeks 6-13). In addition, among subjects who were cigarette smokers, those treated with varenicline were significantly less likely to report heavy drinking during the trial.
  
  
  CONCLUSIONS
  Although varenicline was not significantly more effective than placebo at reducing drinking during the trial, its effects on alcohol craving and mood suggest that future investigation of the mechanism of action of varenicline, as well as additional clinical studies may be warranted. In particular, the findings regarding the influence of smoking status on heavy drinking among varenicline-treated subjects should be investigated in future studies.
authors.affiliation: University of Pennsylvania, Department of Psychiatry, United States. Electronic address: jplebani@upenn.edu.
authors.forename: Jennifer G
authors.initials: JG
authors.lastname: Plebani
authors.forename: Kevin G
authors.initials: KG
authors.lastname: Lynch
authors.forename: Lior
authors.initials: L
authors.lastname: Rennert
authors.forename: Helen M
authors.initials: HM
authors.lastname: Pettinati
authors.forename: Charles P
authors.initials: CP
authors.lastname: O'Brien
authors.forename: Kyle M
authors.initials: KM
authors.lastname: Kampman
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D000437:Alcoholism / Q000188:drug therapy* / Q000523:psychology; D001552:Benzazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010865:Pilot Projects; D011810:Quinoxalines / Q000627:therapeutic use*; D018401:Sample Size; D012907:Smoking / Q000523:psychology; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D011810:Quinoxalines; D000068580:Varenicline
keywords: Alcohol dependence; Nicotine dependence; Pharmacotherapy; Treatment; Varenicline
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