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NCT06194851: CBCT-OT RCT

Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

Recruiting now Phase 2 Last updated 29 May 2025
What this trial tests

Phase 2 trial testing Oxytocin nasal spray in Post-Traumatic Stress Disorder (PTSD) in 240 participants. Currently enrolling.

Timeline
28 October 2024
Primary endpoint
30 April 2028
30 April 2028

Quick facts

Lead sponsorVA Office of Research and Development
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment240
Start date28 October 2024
Primary completion30 April 2028
Estimated completion30 April 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other trials of Oxytocin nasal spray

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Data sources for this page

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.

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