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NCT04228289 · ClinicalTrials.gov registry record · Phase 2

Oxytocin to Treat PTSD

A Phase 2 study of PTSD, sponsored by VA Office of Research and Development.

Completed
Registry status
Phase 2
Development phase
180
Enrollment target
2
Study locations

NCT04228289 is a Phase 2 study of PTSD that has completed, run by VA Office of Research and Development. The registered enrollment target is 180 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04228289, a Phase 2 study of PTSD, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
Phase 2
Development phase
180 participants
Enrollment target
2
Study locations

Study Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans. Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD. However, approximately one-third of Veterans fail to receive an adequate dose of treatment because they prematurely drop out of PE therapy. There is also room to improve PE treatment outcomes. Consistent with the VA Office of Research and Development initiative to develop effective treatments for PTSD, the proposed randomized clinical trial will examine the ability of oxytocin (as compared with placebo) combined with PE to reduce PTSD symptom severity, improve the rate of PTSD symptom reduction, and to enhance PE treatment retention and adherence. This two-site study will leverage the investments made in the nationwide rollout off PE therapy and has the potential to significantly improve mental health care among Veterans, advance the science in this area, and identify mechanisms underlying positive PTSD treatment response. Participants may choose to complete this research study via home-based telemedicine (HBT) care (i.e. service delivery to patients in their homes using consumer friendly, video-conferencing technology). HBT sessions will be delivered via standard desk, laptop computer, tablet, or smartphone using VA approved applications. All procedures that take place via telemedicine will be performed and completed as though they were in-person/in-office

Conditions Studied

PTSD

Interventions

  • OTHER Placebo
  • DRUG Oxytocin

Study Locations (2)

California

  • San Francisco VA Medical Center, San Francisco, CA - San Francisco

South Carolina

  • Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2021-01-01
Est. Completion 2025-08-31
Phase Phase 2

Sponsor

VA Office of Research and Development

1,668 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04228289

The ClinicalTrials.gov registry entry for NCT04228289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04228289 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, South Carolina.

Frequently Asked Questions

What is clinical trial NCT04228289 about?

NCT04228289 is a clinical study titled "Oxytocin to Treat PTSD". Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans. Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD. However, approximately one-third of Veterans fail to receive an adequate dose of treatment because they prematu...

What is the current status of trial NCT04228289?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2021-01-01. Estimated completion is 2025-08-31.

What conditions does trial NCT04228289 study?

This clinical trial studies the following conditions: PTSD.

What interventions are being tested in trial NCT04228289?

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

Who is sponsoring clinical trial NCT04228289?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04228289 being conducted?

This trial has 2 study locations across California, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.