Abstract

Having demonstrated previously the efficacy of topiramate--a sulfamate-substituted fructopyranose derivative-as pharmacotherapy for treating alcohol dependence, promoting abstinence and reducing the harmful psychosocial consequences of drinking, we investigated whether topiramate also promoted 'safe' levels of drinking: < or = 1 and < or = 2 standard drinks/day for women and men, respectively, among alcohol-dependent individuals. In a double-blind, randomized, controlled, 12-week clinical trial conducted in San Antonio, Texas, 75 alcohol-dependent adults received topiramate and 75 received placebo as an adjunct to weekly standardized medication compliance management. For this secondary analysis of data from that trial, we calculated, based on self-reports, specific intervals of up to 30 days of continuous 'safe' drinking for each subject. The average longest 'safe' drinking period was 16.7 days for topiramate recipients versus 8.9 days for placebo recipients. By day 50 of treatment, 44% versus 26.4% had achieved > or = 7 and 30.8% versus 10% had achieved > or = 14 continuous 'safe' drinking days. Similarly, topiramate increased the relative likelihood of continuous 'safe' drinking from 77% for > or = 7 days [relative risk (RR) for achieving continuous 'safe' drinking = 1.77] to threefold for > or = 14 days (RR = 3.37) and fourfold for > or = 28 days (RR = 4.07). Thus, participants who received topiramate were more likely to achieve longer periods of 'safe' drinking compared with those who received placebo. For alcohol-dependent individuals who drank within an abstinence-oriented treatment program, topiramate promoted 'safe' drinking. Topiramate's potential to decrease the public health consequences of hazardous drinking needs to be established in future long-term studies.

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