Post-Traumatic Stress Disorder study: Oxytocin nasal spray vs Saline nasal spray
Official title Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
ClinicalTrials.gov ID: NCT06194851
What this study is testing
What is Oxytocin nasal spray?
This is an investigational nasal spray being studied to see if it helps improve PTSD symptoms and relationship quality when used with therapy. It is designed to work by using a natural hormone that influences social behavior and trust to potentially support the therapy process.
Also referred to as Pitocin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether intranasal oxytocin improves the effectiveness of brief couples therapy for veterans with PTSD. It also looks at how the therapy may change communication, empathy, and trust.
- Who it's for
- You may be able to join if you are a veteran with PTSD and you have a partner who is willing to participate.
- What's involved
- You and your partner would attend a short couples therapy program. Some sessions will include a spray of oxytocin or a pretend spray. You will also answer questions about your relationship and PTSD symptoms.
- Time commitment
- The study lasts about 8 weeks, with several therapy sessions and a few check‑in visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be married, or cohabitating for at least 6 months
- Willing to be assigned by chance into either treatment condition (bCBCT + OT or bCBCT + PL)
- Agree to have assessment and treatment sessions audio/video recorded
You likely can't join if
- Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders...
- Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R).
- Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
- Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
- Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \ 130 or diastolic BP \> 80 mm Hg), and...
- Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76.
See the full eligibility criteria
- 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...
- Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
- Be married, or cohabitating for at least 6 months
- Willing to be assigned by chance into either treatment condition (bCBCT + OT or bCBCT + PL)
- Agree to have assessment and treatment sessions audio/video recorded
- Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjoint therapy during the treatment portion of the study
- Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space)
- 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
- 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.
- Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
- Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
- Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \ 130 or diastolic BP \> 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes).
- 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.
- Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception.
- Known allergy to preservatives (i.e., Methylparaben, Propylparaben, Glycerin, Sodium Benzoate, Potassium Sorbate, and Disodium EDTA) utilized in oxytocin nasal spray.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.