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NCT01847469 · ClinicalTrials.gov registry record · Phase 2

Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence

A Phase 2 study of Alcohol Dependence and Post Traumatic Stress Disorder (PTSD), sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
1
Study location

NCT01847469 is a Phase 2 study of Alcohol Dependence and Post Traumatic Stress Disorder (PTSD) that has completed, run by Yale University. The registered enrollment target is 24 participants, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01847469, a Phase 2 study of Alcohol Dependence and Post Traumatic Stress Disorder (PTSD), has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. Medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will be provided by trained and qualified clinicians with extensive experience providing E-CPT-C. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.

Conditions Studied

Alcohol Dependence Post Traumatic Stress Disorder (PTSD)

Interventions

  • DRUG Placebo
  • DRUG Zonisamide
  • BEHAVIORAL Enhanced-Cognitive Processing Therapy-C (E-CPT-C)

Study Locations (1)

Connecticut

  • VA Connecticut Healthcare System - West Haven

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-06
Est. Completion 2019-01-01
Phase Phase 2

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT01847469

The ClinicalTrials.gov registry entry for NCT01847469 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (92% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01847469 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT01847469 about?

NCT01847469 is a clinical study titled "Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence". This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization will be done using 3:1 rati...

What is the current status of trial NCT01847469?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2013-06. Estimated completion is 2019-01-01.

What conditions does trial NCT01847469 study?

This clinical trial studies the following conditions: Alcohol Dependence, Post Traumatic Stress Disorder (PTSD).

What interventions are being tested in trial NCT01847469?

The interventions under investigation include: Placebo (DRUG), Zonisamide (DRUG), Enhanced-Cognitive Processing Therapy-C (E-CPT-C) (BEHAVIORAL).

Who is sponsoring clinical trial NCT01847469?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01847469 being conducted?

This trial has 1 study location across Connecticut. 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.