Trials / Unknown
UnknownNCT03479086
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- South West Sydney Local Health District · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topiramate | 200mg/day 100mg b.i.d |
| DRUG | Naltrexone | 50mg/day |
Timeline
- Start date
- 2017-06-20
- Primary completion
- 2020-11-01
- Completion
- 2020-11-01
- First posted
- 2018-03-27
- Last updated
- 2018-05-11
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03479086. Inclusion in this directory is not an endorsement.