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Title: Topiramate Effective Treatment for Alcohol Dependence: Presented at APA

"Topiramate Effective Treatment for Alcohol Dependence: Presented at APA"

By Bruce Sylvester SAN FRANCISCO, CA -- May 27, 2003 -- Topiramate, a novel medication for treating alcoholism, "should garner scientific interest since few effective medications are available for this indication," researchers said at the 2003 Annual Meeting of the American Psychiatric Association. Lead investigator Bankole A. Johnson, MD, of the department of psychiatry, University of Texas Health Science Center in San Antonio, Texas, United States, reported their findings here during a poster session on May 21st. "Midbrain and cortical brain reward systems that modulate dopamine function are critical to establishing and maintaining alcohol-seeking behavior," the researchers explained in their poster. "Additionally, chronic alcoholics develop long-term GABA/glutamate neuronal changes that result in negative effect with abstinence." As a result, alcohol-seeking behavior may "be maintained by alcohol's rewarding effects and the desire to avoid abstinence-induced negative effect. Based upon this knowledge, we hypothesized that topiramate, a substituted fructo-pyranose derivative, would reduce alcohol-induced reward and dampen neuronal hyperexcitability following abstinence." These effects initially may be caused by "topiramate-induced facilitation of central GABAergic function and the inhibition of chronic alcohol-mediated supersensitivity of AMPA/kainate glutamate receptors," they wrote. To determine the efficacy of topiramate in the treatment of alcoholism, the investigators enrolled 150 subjects in the 12-week, placebo-controlled, randomized study. All subjects met Diagnostic and Statistical Manual IV criteria for alcohol dependence by scoring 8 or higher on the alcohol use disorders identification test. In the 90 days prior to the study, women reported drinking a mean of at least 21 standard drinks per week, and men reported consuming at least 35 standard drinks per week. A "standard drink" is 12 oz of beer, 5 oz of wine, or 1.5 oz of 80-proof liquor. The investigators balanced the 2 groups by age, baseline drinking (90-day timeline follow-back method), and age of onset of problem drinking. They gave topiramate to 75 subjects at 25 mg/day, titrated upwards at 25-50 mg/week to either 300 mg/day or maximum tolerated dose. The remaining 75 patients received escalating placebo tablets. Average daily dose of topiramate at end point was 120 mg/day. The researchers reported that topiramate up to 300 mg/day was superior to placebo "as an adjunct to medication compliance management at significantly reducing the amount and severity of drinking and the objective measure of alcohol consumption, plasma GGT." "Importantly," they said, "topiramate recipients also had significantly greater improvement in global well-being and psychosocial functioning. Average effect sizes for the therapeutic difference between topiramate and placebo were in the medium range." Dr. Johnson said, "this study has drawn a huge amount of national and international media attention over the past weeks. We hope that will lead to more studies on the potential use of this agent to address the needs of alcohol-dependent patients, whose numbers are staggering and whose addiction respects no boundaries of age." The study was supported by the National Institute of Mental Health, University of Texas Health Science Center at San Antonio, and Ortho-McNeil Pharmaceuticals. [Study title: Topiramate for the Treatment of Alcohol Dependence. Abstract NR636]

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