CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04228289
NCT04228289Phase 2Completed

Enhancing Prolonged Exposure Therapy for PTSD With Oxytocin

VA Office of Research and Development·interventional·Posted Jan 14, 2020·Updated Mar 11, 2026

In Brief

A Phase 2 clinical trial evaluating Oxytocin and Placebo for PTSD. Completed, enrolled 180 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 14, 2020
Enrollment StartJan 1, 2021
Primary CompletionFeb 28, 2025
Study CompletionAug 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.5 years ago

Interventions

Oxytocindrug

40 IU intranasal spray

Placeboother

matching intranasal spray