Oral topiramate reduces the consequences of drinking and improves the quality of life of alcohol-dependent individuals - A randomized controlled trial

Background: Topiramate, a fructopyranose derivative, was superior to placebo at improving the drinking outcomes of alcohol-dependent individuals. Objectives: To determine whether topiramate, compared with placebo, improves psychosocial functioning in alcohol-dependent individuals and to discover how this improvement is related to heavy drinking behavior. Design: Double-blind, randomized, controlled, 12-week clinical trial comparing topiramate vs placebo for treating alcohol dependence (1998-2001). Participants: One hundred fifty alcohol-dependent individuals, diagnosed using the DSM-W. Interventions: Seventy-five participants received topiramate (escalating dose of 25 mg/d to 300 mg/d), and 75 had placebo and weekly standardized medication compliance management. Main Outcome Measures: Three elements of psychosocial functioning were measured: clinical ratings of overall well-being and alcohol-dependence severity, quality of life, and harmful drinking consequences. Overall well-being and dependence severity and quality of life were analyzed as binary responses with a generalized estimating equation approach; harmful drinking consequences were analyzed as a continuous response using a mixed-effects, repeated-measures model. Results: Averaged over the course of double-blind treatment, topiramate, compared with placebo, improved the odds of overall well-being (odds ratio [OR] =2.17; 95% confidence interval [CI], 1. 16-2.60; P=.01); reported abstinence and not seeking alcohol (OR= 2.63; 95% CI, 1.524.53; P=.001); overall life satisfaction (OR=2.28; 95% CI, 1.21-4.29; P=.01); and reduced harmful drinking consequences (OR=-0.07; 95% CI, -0.12 to -0.02, P=.01). There was a significant shift from higher to lower drinking quartiles on percentage of heavy drinking days, which was associated with improvements on all measures of psychosocial functioning. Conclusions: As an adjunct to medication compliance enhancement treatment, topiramate (up to 300 mg/d) was superior to placebo at not only improving drinking outcomes but increasing overall well-being and quality of life and lessening dependence severity and its harmful consequences.