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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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 9 to week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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%

Dizziness

13%

Fatigue

13%

Cognitive Disorder

13%

Nausea

11%

Decreased appetite

Vision blurred

Distubance in attention

Sinusitis

Depression

Deep vein thrombosis

Peripheral arterial occlusive disease

Concussion

Chronic obstructive pulmonary disease

Nephrolithiasis

Pneumonia

Road traffic accident

Dehydration

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met