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Report for Clinical Trial NCT03667846

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With Post Traumatic Stress Disorder

This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.

NCT03667846 Post Traumatic Stress Disorder Alcohol Use Disorder
MeSH:Disease Alcoholism Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Alcohol Drinking

2 Interventions

Name: Topiramate

Description: Generic topiramate, FDA-approve for clinical use, will be purchased in 25mg, 50mg, and 100mg strengths, and encapsulated.
Type: Drug
Group Labels: 1

Topiramate

Name: Placebo

Description: Placebo tablets will be encapsulated in identical capsules.
Type: Other
Group Labels: 1

Placebo

Primary Outcomes

Description: Retrospective estimate of daily alcohol consumption over a time period ranging from 7 days to 24 months prior to initial interview

Measure: Measure of Time-line Follow-back (TLFB)

Time: Day 1

Description: Percentage of day abstinent from alcohol between week 9 and week 12

Measure: Percent Day Abstinent from Alcohol

Time: Week 9 to Week 12

Description: 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Each question is measured on a 5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range - 0-80; 80 being more severe) can be obtained by summing the scores for each of the 20 items.

Measure: PCL-5 score

Time: Week 9 to Week 12
Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs2832407

It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders.

A recent clinical study demonstrated that the effects of topiramate on alcohol use were moderated by a polymorphism of the GRIK1 gene (coding for the kainate receptor GluK1 subunit), such that significant benefit was found only among rs2832407 C-allele homozygotes.

This trial is designed to contrast acute and persisting effects of topiramate to those of placebo treatment in a sample of 150 participants with comorbid PTSD and moderate to severe AUD, and to evaluate the moderating effect of rs2832407 genotype on medication effects.


HPO Nodes