Topiramate, a fructopyranose derivative, was superior to placebo at
improving the drinking outcomes of alcohol-dependent individuals.
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.
Double-blind, randomized, controlled, 12-week clinical trial comparing
topiramate vs placebo for treating alcohol dependence (1998-2001).
One hundred fifty alcohol-dependent individuals, diagnosed using the DSM-IV.
Seventy-five participants received topiramate (escalating dose of 25
mg/d to 300 mg/d), and 75 had placebo and weekly standardized medication compliance
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.
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, 1.52-4.53; 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.
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.