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Drug Alcohol Depend. 2013 Dec 1;133(2):440-6. doi: 10.1016/j.drugalcdep.2013.06.032. Epub 2013 Jul 29.

Topiramate treatment for alcoholic outpatients recently receiving residential treatment programs: a 12-week, randomized, placebo-controlled trial.

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1
Department of Psychiatry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand. Electronic address: surinpor.li@cmu.ac.th.

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.

KEYWORDS:

Alcohol; Detoxification; Inpatient; Placebo; Residential; Topiramate

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