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Oxytocin Nasal Spray for PTSD (CBCT-OT RCT Trial)

Phase 2

Recruiting

Led By Lauren M. Sippel, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study

Be older than 18 years old

Must not have

Severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 6-months post treatment

Summary

This trial is studying a treatment called Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) for couples where one partner has posttraumatic stress disorder (PTSD). The treatment aims to

Who is the study for?

This trial is for veterans with PTSD who are in a relationship. It's designed to help improve both their PTSD symptoms and relationship quality. Participants must be willing to undergo couples therapy and use either an oxytocin or saline nasal spray.

What is being tested?

The study tests if adding oxytocin nasal spray to brief couples therapy (bCBCT) is more effective than just the therapy with a saline placebo. The goal is to see if this combination can better treat PTSD and enhance relationship satisfaction among veterans.

What are the potential side effects?

Oxytocin nasal spray may cause side effects like irritation inside the nose, headache, changes in heart rate or blood pressure, emotional changes, and possibly altered social behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to undergo any other PTSD-focused therapy during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart disease or uncontrolled diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 6-months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 6-months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 6-months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD diagnosis and severity change

Secondary study objectives

Relationship satisfaction

Other study objectives

Communication

Empathy

Psychosocial functioning

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal OxytocinExperimental Treatment2 Interventions

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin.

Group II: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal PlaceboPlacebo Group2 Interventions

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxytocin nasal spray

2016

Completed Phase 4

~1480

Brief Cognitive-Behavioral Conjoint Therapy

2022

Completed Phase 2

~20