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NCT03667846 · ClinicalTrials.gov registry record · Phase 2

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

A Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress Disorder, sponsored by NYU Langone Health.

Recruiting
Registry status
Phase 2
Development phase
150
Enrollment target
1
Study location

NCT03667846 is a Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 150 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03667846, a Phase 2 study of Alcohol Use Disorder and Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by NYU Langone Health.

RECRUITING
Registry status
Phase 2
Development phase
150 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Alcohol Use Disorder Post Traumatic Stress Disorder

Interventions

  • OTHER Placebo
  • DRUG Topiramate

Study Locations (1)

New York

  • New York University School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2019-10-10
Est. Completion 2025-08-31
Phase Phase 2

Sponsor

NYU Langone Health

1,164 total trials

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What the Registry Record Tells You About NCT03667846

The ClinicalTrials.gov registry entry for NCT03667846 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (54% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03667846 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03667846 about?

NCT03667846 is a clinical study titled "Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD". 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 c...

What is the current status of trial NCT03667846?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-10-10. Estimated completion is 2025-08-31.

What conditions does trial NCT03667846 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Post Traumatic Stress Disorder.

What interventions are being tested in trial NCT03667846?

The interventions under investigation include: Placebo (OTHER), Topiramate (DRUG).

Who is sponsoring clinical trial NCT03667846?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03667846 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.