This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbin 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.
Name: TopiramateDescription: Generic topiramate, FDA-approve for clinical use, will be purchased in 25mg, 50mg, and 100mg strengths, and encapsulated.Type: Drug
Name: PlaceboDescription: Placebo tablets will be encapsulated in identical capsules.Type: Other
Description: Retrospective estimate of daily alcohol consumption over a time period ranging from 7 days to 24 months prior to initial interviewMeasure: Measure of Time-line Follow-back (TLFB) Time: Day 1
Description: Percentage of day abstinent from alcohol between week 9 and week 12Measure: 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
There is one SNP
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.