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Report for Clinical Trial NCT03479086
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
NCT03479086 Alcohol Dependence MeSH:Alcoholism
2 Interventions
Name: Topiramate
Name: Naltrexone
Primary Outcomes
Description: Corroborated with Phosphatidylethanol (PEth) levels
Measure: Number of heavy drinking days, as measured by the Time Line Follow Back Time: Over 12 weeksDescription: Corroborated with PEth levels
Measure: Time to relapse, as measured by the Time Line Follow Back Time: Over 12 weeksDescription: Corroborated with PEth levels
Measure: Time to lapse, as measured by the Time Line Follow Back Time: Over 12 weeksDescription: Corroborated with PEth levels
Measure: Number of days abstinent, as measured by the Time Line Follow Back Time: Over 12 weeksDescription: Corroborated with PEth levels
Measure: Number of standard drinks per drinking day, as measured by the Time Line Follow Back Time: 12 weeksSecondary Outcomes
Description: as reported by patient during weekly medical management sessions facilitated by the treating doctor.
Measure: Self report of adverse events Time: 12 weeksDescription: 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.
Measure: Penn Alcohol Craving Scale for alcohol craving Time: 12 weeksDescription: as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
Measure: DASS21 score for presence and/or severity of anxiety Time: 12 weeksDescription: as measured by cumulative score for depression related questions
Measure: DASS21 score for presence and/or severity of depression Time: 12 weeksDescription: 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
Measure: Insomnia Severity Index for sleep disturbances Time: 12 weeksDescription: as measured by fasting blood glucose levels in blood
Measure: Blood glucose test for diabetes Time: 12 weeksDescription: as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
Measure: Liver function tests for clinical markers of liver injury Time: 12 weeksDescription: 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.
Measure: Body Mass Index Time: 12 weeksMeasure: Number of cigarettes smoked daily, as measured by Time Line Follow Back Time: 12 weeks
Description: as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
Measure: Self report of daily measures of expectancies, confidence and drinking Time: 12 weeksOther Outcomes
Measure: The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days Time: 12 weeksMeasure: Cost-effectiveness of topiramate versus naltrexone, as measured by Disability-Adjusted Life Years (DALYs) Time: 12 weeks
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs2832407
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.