Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
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|ClinicalTrials.gov Identifier: NCT03479086|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Topiramate Drug: Naltrexone||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
200mg/day 100mg b.i.d
- Number of heavy drinking days, as measured by the Time Line Follow Back [ Time Frame: Over 12 weeks ]Corroborated with Phosphatidylethanol (PEth) levels
- Time to relapse, as measured by the Time Line Follow Back [ Time Frame: Over 12 weeks ]Corroborated with PEth levels
- Time to lapse, as measured by the Time Line Follow Back [ Time Frame: Over 12 weeks ]Corroborated with PEth levels
- Number of days abstinent, as measured by the Time Line Follow Back [ Time Frame: Over 12 weeks ]Corroborated with PEth levels
- Number of standard drinks per drinking day, as measured by the Time Line Follow Back [ Time Frame: 12 weeks ]Corroborated with PEth levels
- Self report of adverse events [ Time Frame: 12 weeks ]as reported by patient during weekly medical management sessions facilitated by the treating doctor.
- Penn Alcohol Craving Scale for alcohol craving [ Time Frame: 12 weeks ]as measured by amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol.
- DASS21 score for presence and/or severity of anxiety [ Time Frame: 12 weeks ]as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
- DASS21 score for presence and/or severity of depression [ Time Frame: 12 weeks ]as measured by cumulative score for depression related questions
- Insomnia Severity Index for sleep disturbances [ Time Frame: 12 weeks ]as measured by cumulative score of satisfaction with current sleep patterns and extent to which sleep disturbances interfere and impair with every day activities and daily functioning
- Blood glucose test for diabetes [ Time Frame: 12 weeks ]as measured by fasting blood glucose levels in blood
- Liver function tests for clinical markers of liver injury [ Time Frame: 12 weeks ]as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
- Body Mass Index [ Time Frame: 12 weeks ]as measured by weight in kilograms (kg) and height in metres (m). These two measurements will be combined together to report BMI in kg/m^2.
- Number of cigarettes smoked daily, as measured by Time Line Follow Back [ Time Frame: 12 weeks ]
- Self report of daily measures of expectancies, confidence and drinking [ Time Frame: 12 weeks ]as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
- The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days [ Time Frame: 12 weeks ]
- Cost-effectiveness of topiramate versus naltrexone, as measured by Disability-Adjusted Life Years (DALYs) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479086
|Contact: Kirsten Morley, PhDemail@example.com|
|Australia, New South Wales|
|Drug Health Services, Royal Prince Alfred Hospital||Recruiting|
|Sydney, New South Wales, Australia, 2050|
|Contact: Kirsten C Morley, PhD +61295153636 firstname.lastname@example.org|
|Contact: Central Intake 95157611 email@example.com|
|Principal Investigator: Paul Haber, MBBS|
|Principal Investigator:||Paul S Haber, MBBS||Sydney Local Health District|
|Principal Investigator:||Andrew Baillie, PhD||Macquarie University|
|Principal Investigator:||Kirsten C Morley, PhD||University of Sydney|