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Prolonged Exposure and Oxytocin | Clinical Trials | Clareo Health

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Prolonged Exposure and Oxytocin

Augmenting Prolonged Exposure Therapy for PTSD With Intranasal Oxytocin

NCT03238924•Medical University of South Carolina

Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events. Prolonged Exposure (PE) is a cognitive-behavioral psychotherapy modality with a wealth of empirical support demonstrating its efficacy to treat PTSD in a variety of populations. The neuropeptide oxytocin is a promising new pharmacotherapeutic agent with prominent anxiolytic effects . Despite a strong biological and theoretical rationale for investigating the potential effectiveness of augmenting PE with intranasal oxytocin, no studies to date have done so. The current study aims to address this important gap in the literature by examining changes in PTSD symptoms following PE treatment combined with a) 40 IU of intranasal oxytocin or b) placebo.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female; any race or ethnicity; age 18-75 years.
•2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
•3. Participants must be able to comprehend English.
•4. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS).
•5. A CAPS score of 50 or greater.

Exclusion Criteria

•7. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. Initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
•1. Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those participants will be referred clinically.
•2. Participants who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those participants will be referred clinically.
•3. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
•4. Participants meeting DSM-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months.
•5. Pregnant women will be excluded from the proposed study.

Key Dates

Start Date

January 1, 2015

Primary Completion Date

December 31, 2016

Completion Date

December 31, 2016

Last Updated

May 25, 2018

Enrollment

ACTUAL participants

Conditions

PTSD

Interventions

Oxytocin

DRUG

Placebos

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prolonged Exposure and Oxytocin

Inclusion Criteria

Exclusion Criteria

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