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Anti-epileptic drug

Topiramate for AUD and PTSD

Phase 2
Recruiting
Led By Charles Marmar, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females aged 18-70 years old
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)
Must not have
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 serious suicide attempts requiring hospitalization, or active homicidality
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 > 2.0 x ULN; or c) ALT or AST ≥ 3 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9 to week 12
Awards & highlights

Summary

This trial is testing whether the drug topiramate can help people who have both PTSD and AUD. It will be the first study to see if the rs2832407 genotype predicts how well someone does on topiramate.

Who is the study for?
Adults aged 18-70 with both PTSD and moderate-to-severe alcohol use disorder (AUD) who want to reduce or stop drinking can join. They must be willing to use contraception if applicable, have a stable living situation, and have had several heavy drinking days recently. Excluded are those with significant health issues like liver or kidney problems, certain severe mental health conditions, recent inpatient psychiatric treatment (except for detox), current severe substance abuse other than alcohol/nicotine, or on conflicting medications.Check my eligibility
What is being tested?
The trial is testing the effectiveness of topiramate compared to a placebo in treating people who suffer from both PTSD and AUD. It's double-blind meaning neither participants nor researchers know who gets the real drug versus placebo. The study also explores whether genetic factors influence how well topiramate works for these conditions.See study design
What are the potential side effects?
Topiramate may cause side effects such as tingling sensations in limbs, taste changes leading to weight loss, difficulty concentrating, fatigue, dizziness or balance issues. More serious but less common effects include vision problems and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have been diagnosed with PTSD or subPTSD according to the DSM-5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a serious mental health condition and have not had recent severe suicidal or homicidal behavior.
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My liver is not working well, shown by high enzyme levels and symptoms like fatigue or pain.
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My kidneys are not working well (creatinine clearance rate is below 70).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure of Time-line Follow-back (TLFB)
PCL-5 score
Percent Day Abstinent from Alcohol

Side effects data

From 2017 Phase 4 trial • 282 Patients • NCT02191579
31%
Paraesthesia
13%
Fatigue
13%
Dizziness
13%
Cognitive Disorder
13%
Nausea
11%
Decreased appetite
8%
Distubance in attention
8%
Vision blurred
7%
Sinusitis
6%
Depression
1%
Peripheral arterial occlusive disease
1%
Deep vein thrombosis
1%
Concussion
1%
Chronic obstructive pulmonary disease
1%
Nephrolithiasis
1%
Pneumonia
1%
Road traffic accident
1%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate
BOTOX®

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TopiramateExperimental Treatment1 Intervention
Week 0-1: 25 mg qhs Week 1-2: 25 mg qAM, 25 mg qhs Week 2-3: 25 mg qAM, 50 mg qhs Week 3-4: 50 mg qAM, 50 mg qhs Week 4-5: 50 mg qAM, 75 mg qhs Week 5-6: 75 mg qAM, 75 mg qhs Week 6-7: 75 mg qAM, 100 mg qhs Week 7-8: 100 mg qAM, 100 mg qhs Week 8-10: 100 mg qAM, 100 mg qhs Week 10-12: 100 mg qAM, 100 mg qhs Week 12-14: 2-week taper
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topiramate
2013
Completed Phase 4
~3400

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,968 Total Patients Enrolled
11 Trials studying Alcoholism
1,306 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
815 Previous Clinical Trials
1,159,721 Total Patients Enrolled
428 Trials studying Alcoholism
778,149 Patients Enrolled for Alcoholism
Charles Marmar, MDPrincipal InvestigatorNYU Langone Health
7 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Alcoholism
95 Patients Enrolled for Alcoholism

Media Library

Topiramate (Anti-epileptic drug) Clinical Trial Eligibility Overview. Trial Name: NCT03667846 — Phase 2
Alcoholism Research Study Groups: Placebo, Topiramate
Alcoholism Clinical Trial 2023: Topiramate Highlights & Side Effects. Trial Name: NCT03667846 — Phase 2
Topiramate (Anti-epileptic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03667846 — Phase 2
~3 spots leftby Aug 2024