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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9 to week 12
Awards & highlights

Study 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
Select...
I am between 18 and 70 years old.
Select...
I have been diagnosed with PTSD or subPTSD according to the DSM-5.

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
1,368 Previous Clinical Trials
839,576 Total Patients Enrolled
11 Trials studying Alcoholism
1,306 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,847 Total Patients Enrolled
423 Trials studying Alcoholism
985,558 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility threshold for this trial capped at seventy-five years?

"To be eligible for this medical experiment, potential participants must fall between 18 and 70 years of age. Clinicialtrials.gov indicates that there are 324 studies available to those younger than 18 and 1068 trials open to seniors beyond 65 years old."

Answered by AI

Are more participants being solicited for this experiment?

"Affirmative. The information on clinicaltrials.gov reveals that this trial, first posted in October 16th 2019, is actively searching for participants. 150 volunteers need to be enrolled from a single site."

Answered by AI

Who is eligible to become a participant in this medical experiment?

"This clinical trial requires 150 individuals with stress-induced traumatic histories that are 18 and 70 years of age. Most notably, applicants should have had at least 4 days (4 for women, 5 for men) where they drank heavily in the month prior to screening while also expressing a desire to decrease or end their consumption. Furthermore, two reliable contacts must be provided as reference points."

Answered by AI

How many participants have been accepted into this medical study?

"Affirmative. According to medical records hosted on clinicaltrials.gov, this research initiative is currently recruiting participants with the initial post dating back to October 16th 2019 and most recent update being September 27th 2022. There are 1 sites looking for a total of 150 volunteers."

Answered by AI

What indications is Topiramate typically prescribed for?

"Topiramate is a commonly prescribed medication used to treat hypertension, migraines and epilepsy. Additionally, this drug may be taken as countermeasure for obesity-related comorbidities."

Answered by AI

Has Topiramate been certified by the Food and Drug Administration?

"Our medical researchers at Power have judged the safety of Topiramate to be a 2, as there is some evidence in Phase 2 trials that it is safe but no data demonstrating efficacy."

Answered by AI

Have there been any other investigations involving the use of Topiramate?

"Currently, there are 18 active studies researching the effects of Topiramate with 3 trials in Phase 3. Despite most locations for these experiments being situated around Sherbrooke, Quebec; 30 sites are participating total."

Answered by AI

Who else is applying?

What site did they apply to?
New York University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
2019. "Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03667846.
All > Alcoholism > Ptsd
~10 spots leftby Aug 2024
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