Is NCT03667846 recruiting in New York, NY?

Yes, NCT03667846 is currently recruiting participants at its New York, NY location. This post traumatic stress disorder clinical trial is actively enrolling qualified participants.

How do I join the post traumatic stress disorder clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Post Traumatic Stress Disorder Clinical Trial in New York, NY

About This Post Traumatic Stress Disorder Study in New York

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.

Sponsor: NYU Langone Health

Who Can Participate

Inclusion 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 (CAPS-5)

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

Exclusion Criteria

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 serious suicide attempts requiring hospitalization, or active homicidality

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 eligibility.

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 \> 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

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 pharmacologic treatments for addictions including alcohol use disorder ,and other Carbonic Anhydrase inhibitors (i.e. zonisamide, acetazolamide, dichlorphenamide). Oral contraceptives are permitted as long as participants who are on an estrogen and/or estrogen-progesterone form use a double barrier contraceptive. Antidepressant medications are permitted if participants have been on a stable dose for at least 4 weeks prior to screening and the dose may not be changed during treatment phase (weeks 0-14) of the study.

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 personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)

Inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT03667846) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Post Traumatic Stress Disorder Treatment Options in New York, NY

If you're searching for post traumatic stress disorder treatment options in New York, NY, this clinical trial (NCT03667846) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced post traumatic stress disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all post traumatic stress disorder clinical trials near you to find additional studies recruiting in your area.

Post Traumatic Stress Disorder Clinical Trial in New York, NY

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