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NCT06194851: CBCT-OT RCT
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Phase 2 trial testing Oxytocin nasal spray in Post-Traumatic Stress Disorder (PTSD) in 240 participants. Currently enrolling.
30 April 2028
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 28 October 2024 |
| Primary completion | 30 April 2028 |
| Estimated completion | 30 April 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oxytocin nasal spray — full drug profile →
- Saline nasal spray — full drug profile →
- Brief Cognitive-Behavioral Conjoint Therapy
Conditions studied
- Post-Traumatic Stress Disorder (PTSD) — all drugs for Post-Traumatic Stress Disorder (PTSD) →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
18 and older, any sex, with Post-Traumatic Stress Disorder (PTSD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among Veterans. Pharmacological augmentation of bCBCT with intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve the efficacy of bCBCT. The purpose of this randomized placebo-controlled trial is to compare the clinical and functional outcomes of bCBCT augmented with intranasal oxytocin (bCBCT + OT) versus bCBCT plus placebo (bCBCT + PL). The investigators will also explore potential mechanisms of action: communication, empathy, and trust.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Design of a randomized clinical trial of brief couple therapy for PTSD augmented with intranasal oxytocin.
Sippel LM, Wachsman TR, Kelley ME, Knopp KC, et al · · 2024 · cited 2× · PMID 38614447 · DOI 10.1016/j.cct.2024.107534
Verify or expand the search:
- PubMed search for NCT06194851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oxytocin nasal spray
Trials testing the same drug.
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- NCT05934812 — Intranasal Oxytocin in Youth With Autism · Phase 2 · not yet recruiting
- NCT06881810 — Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment · Phase 2 · recruiting
- NCT06332066 — Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness · Phase 1 · unknown
- NCT06248710 — Dog Presence and Oxytocin on Trust Towards Therapists · Phase 2, PHASE3 · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06194851 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 29 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06194851.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing