Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia

Last updated: May 4, 2018
Sponsor: South West Sydney Local Health District
Overall Status: Active - Recruiting

Phase

3

Condition

Alcohol Use Disorder

Alcohol Dependence

Addictions

Treatment

N/A

Clinical Study ID

NCT03479086
X16-0231
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Alcohol Use Disorder according to the Diagnostic and Statistical Manual of MentalDisorders Version V criteria

  • Age 18-70

  • Average weekly alcohol consumption of >30 standard drinks for men and >25 standarddrinks for women, with a weekly average of > 2 heavy drinking days during the monthbefore screening

  • Adequate cognition and English language skills to give valid consent and completeresearch interviews

  • Willingness to give written informed consent

  • Willingness to provide a blood sample for genotyping

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Active major psychological disorder associated with psychosis, significant suiciderisk, and signs of impaired cognitive functioning

  • Pregnancy or lactation

  • Concurrent use of any psychotropic medication other than antidepressants

  • Currently taking any tricyclic antidepressant

  • Use of antiretroviral dolutegravir

  • Any substance dependence other than nicotine

  • Opioid abuse, opioid dependence, or on opioid maintenance treatment

  • Clinically significant liver disease

  • History of nephrolithiasis

  • History of glaucoma

  • Lack of stable housing and/or contact phone number

  • Previous hypersensitivity to TOP or NTX

  • Any alcohol pharmacotherapy within the past month

Study Design

Total Participants: 180
Study Start date:
June 20, 2017
Estimated Completion Date:
November 01, 2020

Study Description

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.

Connect with a study center

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

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