Oxytocin to Treat PTSD

July 26, 2023 updated by: VA Office of Research and Development

Enhancing Prolonged Exposure Therapy for PTSD With Oxytocin

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. PTSD is a chronic disorder that is associated with significant morbidity, mortality, disability, and costly health care expenditures. The clinical impairment associated with PTSD among Veterans is severe and associated with comorbid depression, suicidality, substance abuse, physical health problems, interpersonal violence, and neuropsychiatric impairment. Despite these pervasive health consequences, the current treatment services offered to Veterans do not adequately address PTSD. Several promising psychosocial interventions, including Prolonged Exposure (PE) therapy, have been developed for the treatment of PTSD. Although PE is one of the most widely used evidence-based treatments for PTSD, there is substantial room for improvement in outcomes and retention rates. For example, approximately one-third of patients dropout of PE treatment prematurely, and the highest dropout rates occur among Veterans. Consistent with the VA Office of Research and Development initiative to develop effective treatments for PTSD, identifying pharmacotherapies to enhance PTSD treatment retention and outcomes is critical. Accumulating data from the investigators' group and others suggests that oxytocin is a promising candidate to achieve this goal. Oxytocin is known to promote prosocial behaviors associated with successful psychosocial treatment outcomes (e.g., trust, safety, social cognition) and has demonstrated positive effects on extinction learning in animal and human stress models. Furthermore, recent neuroimaging studies show that oxytocin has the ability to ameliorate dysregulation of the corticolimbic brain circuitry, which is a central component of the pathophysiology and maintenance of PTSD. In the only study to date examining the feasibility, acceptability, and preliminary efficacy of augmenting PE with oxytocin, the investigators' group found that participants randomized to the oxytocin condition demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores compared to participants randomized to the placebo condition. Therefore, the primary objective of the proposed two-site Phase II study is to examine the ability of oxytocin (vs. placebo) combined with PE therapy to (1) reduce PTSD symptom severity, (2) improve rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, the investigators will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). The proposed study directly addresses the mission of the Veterans Health Administration Blueprint for Excellence in that it seeks to advance personalized and proactive mental health care opportunities for Veterans. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the neurobiological mechanisms underlying PTSD and positive 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 Type

Interventional

Enrollment (Estimated)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • Recruiting
        • San Francisco VA Medical Center, San Francisco, CA
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5703
        • Recruiting
        • Ralph H. Johnson VA Medical Center, Charleston, SC
        • Contact:
        • Principal Investigator:
          • Julianne Christina Flanagan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veteran
  • Any race or ethnicity
  • Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (> 26 on the Mini Mental Status Exam)

  • Meet DSM-5 diagnostic criteria for current (i.e., past 6 months) PTSD (assessed via the CAPS-5)

    • participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria)
    • anxiety disorders (e.g. panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder)
  • Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation

Exclusion Criteria:

  • Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent

    • those participants will be referred clinically
  • Participants who present a serious suicide risk or are likely to require hospitalization during the study
  • Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks
  • Pregnancy or breastfeeding for women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin
40 IU intranasal oxytocin
Drug: Oxytocin
40 IU intranasal spray
Other Names:
  • Pitocin
Placebo Comparator: Placebo
intranasal saline spray
Other: Placebo
matching intranasal spray
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time Frame: End of Treatment (10 weeks)
Total CAPS-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
End of Treatment (10 weeks)
PTSD Symptom Severity as measured by the PTSD Checklist (PCL-5)
Time Frame: End of Treatment (10 weeks)
Total PCL-5 Scores range from 17-85. Higher scores indicate greater symptom severity.
End of Treatment (10 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sessions attended
Time Frame: End of Treatment (10 weeks)
Total number of sessions attended during the treatment phase
End of Treatment (10 weeks)
Number of homework assignments completed
Time Frame: End of Treatment (10 weeks)
Total number and proportion of completed homework assignments during treatment phase
End of Treatment (10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

San Francisco VA Health Care System

Investigators

  • Principal Investigator: Julianne Christina Flanagan, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBB-001-19S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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