Prolonged Exposure and Oxytocin
Condition: PTSD
Intervention: Oxytocin; Placebos
Intervention description: 40 IU oxytocin nasal spray, self-administered; Saline nasal spray, self-administered
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: posttraumatic stress disorder; oxytocin; Prolonged Exposure

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 criteria:

        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.

          6. Participants may also meet criteria for a mood disorder (except bipolar affective
             disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social
             phobia, generalized anxiety disorder). The inclusion of participants with affective
             and anxiety disorders is essential because of the marked frequency of the co-existence
             of mood and other anxiety disorders among patients with PTSD.

          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.

        Exclusion Criteria:

          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.