Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 18-70 years old 2. DSM-5 diagnosis of moderate or severe AUD (using SCID5) 3. Endorse a desire to cut down or stop drinking 4. At least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to screen 5. DSM-5 current diagnosis of PTSD with the Clinician Administered PTSD Scale OR subPTSD diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria B-E) with Clinician Administered PTSD Scale (CAPS-5) 6. If of childbearing potential (male or female), are willing to use contraception for duration of the trial 7. Able to provide at least 2 locators 8. Able to provide voluntary informed consent 9. Confirms they are reliably domiciled Exclusion Criteria: 1. Current alcohol withdrawal (CIWA-Ar score \>7) 2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I, current significant suicidality (assessed using the C-SSRS), any significant