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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

Description: 200mg/day 100mg b.i.d

Type: Drug

Topiramate

Name: Naltrexone

Description: 50mg/day

Type: Drug

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 weeks

Description: Corroborated with PEth levels

Measure: Time to relapse, as measured by the Time Line Follow Back

Time: Over 12 weeks

Description: Corroborated with PEth levels

Measure: Time to lapse, as measured by the Time Line Follow Back

Time: Over 12 weeks

Description: Corroborated with PEth levels

Measure: Number of days abstinent, as measured by the Time Line Follow Back

Time: Over 12 weeks

Description: Corroborated with PEth levels

Measure: Number of standard drinks per drinking day, as measured by the Time Line Follow Back

Time: 12 weeks

Secondary Outcomes

Description: as reported by patient during weekly medical management sessions facilitated by the treating doctor.

Measure: Self report of adverse events

Time: 12 weeks

Description: 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 weeks

Description: 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 weeks

Description: as measured by cumulative score for depression related questions

Measure: DASS21 score for presence and/or severity of depression

Time: 12 weeks

Description: 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 weeks

Description: as measured by fasting blood glucose levels in blood

Measure: Blood glucose test for diabetes

Time: 12 weeks

Description: 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 weeks

Description: 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 weeks

Measure: 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 weeks

Other Outcomes

Measure: The moderating effect of the OPRM1 polymorphism in response to naltrexone, as measured by number of heavy drinking days

Time: 12 weeks

Measure: 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.



HPO Nodes