Alcohol Dependence Clinical Trial
Official title:
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.
Clinicians urgently require new treatment strategies for the treatment of alcohol dependence.
Although alcohol use disorders are a leading cause of preventable death in Australia, their
treatment is generally not evidence based. The medications currently approved for use in
Australia for the management of alcohol dependence have limited efficacy, and existing
research does not address the heterogeneity of treatment response.
Targeted personalised medicine addresses this heterogeneity with better medicine selection
for patients based on their genotype and clinical comorbidities.
Members of our research team have recently demonstrated findings that support the use of
topiramate (TOP) 200 mg/day to reduce heavy drinking and pharmacogenetic findings that
implicate the GluK1 receptor subunit in the mechanism of these effects.
This project will evaluate the clinical effectiveness and tolerability of topiramate relative
to the active control naltrexone (NTX) in heavy drinkers.
Investigators hypothesise that topiramate treated patients will be better able to achieve a
reduction in heavy drinking and predict that, based on prior research, that the effects would
be moderated by a single nucleotide polymorphism (rs2832407) in GRIK1.
Research personnel will utilise an innovative prospective pharmacogenetic randomisation
approach to a double-blind, randomised, controlled trial.
Individuals will receive 12 weeks of titrated treatment with topiramate (200 mg/day) or
naltrexone (50mg/day) and medical management.
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