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Can a love hormone help veterans heal from PTSD?

NCT ID NCT06194851

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving oxytocin nasal spray before couples therapy can help veterans with PTSD feel better and improve their relationships. About 240 veterans and their partners will take part. Half get oxytocin, half get a placebo, and all receive eight sessions of brief couples therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oxytocin nasal spray
What this could lead to
If it works, this could offer a way to boost couples therapy for PTSD, helping veterans feel better and strengthen their relationships.
What could go wrong
This is a Phase 2 trial, so it's still early. The oxytocin may not add much benefit over therapy alone, and side effects from the nasal spray are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion criteria for Veteran: 1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery) 2. Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable) 3. Be enrolled and eligible to receive care at the VASDHS Inclusion criteria for Partner: 4. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5) Inclusion criteria for Veteran and Partner: 5. Be married, or cohabitating for at least 6 months 6. Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL) 7. Agree to have assessment and treatment sessions audio/video recorded 8. Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjoint therapy during the treatment portion of the study 9. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space) Exclusion Criteria: Exclusion criteria for Veteran and Partner: 10. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)74 and Drug Abuse Screening Test (DAST)75 11. Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined following case consult by PI or other clinician. 12. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS) 13. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy 14. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in the past year Exclusion criteria for Veteran: 15. Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (systolic BP \>130 or diastolic BP \> 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion to be determined in collaboration with study physician following completion of physician's one-on-one appointment with Veteran and review of all relevant information (e.g., risk factors, health history, concomitant medications, etc.) from Veteran's VA medical record and study screening/assessment processes including selfreport measures and blood pressure measurement. Additionally, Veterans for whom the study physician has elevated concern, will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment. 16. Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76. Exclusion to be determined following case consult by PI or other clinician. 17. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception. If able to become pregnant, Veteran must have a highly sensitive negative urine pregnancy test verified visually via telehealth or in-person at the Veterans Medical Research Foundation by research staff at study entry and prior to each medication administration during treatment. Veteran must verbally confirm that they completed the test themselves that day. Veteran must also agree to use an effective birth control method from study entry until conclusion of treatment to prevent pregnancy. The ability to become pregnant is defined as: assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Effective birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, oral hormones, a barrier contraception method (e.g., male or female condoms, diaphragm, cap), or vasectomized sole sexual partner. Pregnancy tests will be purchased by the study and mailed to Veteran unless PI has approved waiver of testing requirement. 18. Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • VA San Diego Healthcare System, San Diego, CA

    RECRUITING

    San Diego, California, 92161-0002, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.