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New treatment option for Post Traumatic Stress Disorder
Official title Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
ClinicalTrials.gov ID: NCT03667846
What this study is testing
What is Topiramate?
Topiramate is an investigational medicine, being studied as a potential treatment for post traumatic stress disorder.
Also referred to as Topamax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Males and females aged 18-70 years old
- DSM-5 diagnosis of moderate or severe AUD (using SCID5)
- Endorse a desire to cut down or stop drinking
- 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
- 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...
You likely can't join if
- Current alcohol withdrawal (CIWA-Ar score \>7)
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I, current significant suicidality (assessed using the C-SSRS), any...
- DSM-5 diagnosis of current severe substance use disorder for a substance other than alcohol or nicotine
- Any history of severe traumatic brain injury (assessed using the OSU TBI-ID modified). If current (past 12 months) mild/moderate TBI and CSI score...
- Exposure to trauma in the last 30 days, including police duty or military service
- Significantly impaired liver function defined as a) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 x upper limit of...
See the full eligibility criteria
- Males and females aged 18-70 years old
- DSM-5 diagnosis of moderate or severe AUD (using SCID5)
- Endorse a desire to cut down or stop drinking
- 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
- 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...
- If of childbearing potential (male or female), are willing to use contraception for duration of the trial
- Able to provide at least 2 locators
- Able to provide voluntary informed consent
- Confirms they are reliably domiciled
- Current alcohol withdrawal (CIWA-Ar score \>7)
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I, current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of...
- DSM-5 diagnosis of current severe substance use disorder for a substance other than alcohol or nicotine
- Any history of severe traumatic brain injury (assessed using the OSU TBI-ID modified). If current (past 12 months) mild/moderate TBI and CSI score ≥12 (for either lifetime month or current month), the PI will determine...
- Exposure to trauma in the last 30 days, including police duty or military service
- Significantly impaired liver function defined as a) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN); b) ALT or AST \> 3 x ULN with concomitant total bilirubin \>...
- Other medical conditions which would preclude safe participation in the study
- Significant laboratory abnormalities, including significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel
- Current use of medications with the potential for adverse drug-drug interactions including but not limited to CNS depressants specified anticonvulsants (such as: Phenytoin, Carbamazepine and Depakote), metformin, and...
- Pregnancy or lactation
- Current treatment for AUD (with the exception of AA/12-step treatment and/or psychosocial treatment initiated more than 2 months prior to the screening visit)
- Current treatment for methadone or opioid abuse
- Psychotherapy for PTSD or other psychiatric condition, if initiated within 3 months of screening
- Allergy or hypersensitivity to topiramate
- Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
- Significantly impaired renal function defined as) creatinine clearance rate \<70 mL/min/1.73 m2.
- High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process, based on investigator's clinical evaluation (e.g., evidence of serious...
- Inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.