title: Topiramate treatment for alcoholic outpatients recently receiving residential treatment programs: a 12-week, randomized, placebo-controlled trial.
abstract: BACKGROUND
  Initiation of a relapse prevention medication is crucial at the end of alcohol detoxification. This study aimed to examine the efficacy and safety of topiramate for alcoholism in patients receiving a residential treatment program of alcohol detoxification and post-acute treatment.
  
  
  METHODS
  This was a 12-week, randomized, double-blind, placebo-controlled trial of topiramate for alcoholism in patients receiving a residential treatment program. Individuals with DSM-IV alcohol dependence with minimal withdrawal were enrolled. Participants were randomly assigned to receive either 100-300 mg/day of topiramate or placebo. Primary outcomes were given as percentages of heavy drinking days and time to first day of heavy drinking. Other drinking outcomes, craving, and health-related quality of life were evaluated.
  
  
  RESULTS
  A total of 106 participants were randomized to receive topiramate (n=53) or placebo (n=53). Twenty-eight participants of the topiramate group (52.8%) and 25 participants of the placebo group (47.2%) completed the study. Averaged over the trial period, there was no significant difference between groups on the mean percentages of heavy drinking days [1.96 (-1.62 to 5.54), p=.28]. Log rank survival analysis found no difference of time to first day of heavy drinking between topiramate and placebo groups (61.8 vs. 57.5 days, respectively; χ(2)=0.61, d.f.=1, p=.81). Other secondary outcomes were not significantly different between groups.
  
  
  CONCLUSIONS
  By using a conservative model for data analysis, we could not detect the effectiveness of topiramate in this particular population. As the sensitivity analysis showed a trend of its benefit, further studies in larger sample sizes are still warranted.
authors.affiliation: Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand. Electronic address: surinpor.li@cmu.ac.th.
authors.forename: Surinporn
authors.initials: S
authors.lastname: Likhitsathian
authors.forename: Kanok
authors.initials: K
authors.lastname: Uttawichai
authors.forename: Hathaichonnee
authors.initials: H
authors.lastname: Booncharoen
authors.forename: Apisak
authors.initials: A
authors.lastname: Wittayanookulluk
authors.forename: Chaisiri
authors.initials: C
authors.lastname: Angkurawaranon
authors.forename: Manit
authors.initials: M
authors.lastname: Srisurapanont
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010045:Outpatients; D010349:Patient Compliance; D012114:Residential Treatment; D055502:Secondary Prevention; D000077236:Topiramate; D016896:Treatment Outcome
chemical_list: D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose
keywords: Alcohol; Detoxification; Inpatient; Placebo; Residential; Topiramate