The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.

Official Title
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The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18 to 65 years of age Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI) No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months. Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures. Subjects must be able to give informed consent and be willing and able to comply with study procedures. Exclusion Criteria: Presence of a current DSM-IV Axis I diagnosis as measured by the SCID. A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult. Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary). Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics. Pregnant or lactating women. Women of childbearing potential not using medically accepted forms of contraception. Current use of the excluded psychiatric medications. Known hypersensitivity to oxytocin Known hyponatremia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matched nasal spray placebo. | Drug: Placebo<br>* Matched nasal spray placebo<br>|
| Experimental: Oxytocin<br>Liquid intranasal oxytocin administered in a nasal spray. | Drug: Oxytocin<br>* Liquid metered-dose nasal spray, 30 IUs, administered once.<br>* Other names: Syntocinon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential Skin Conductance Response (SCR) During the First Two Extinction Trials | Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation. | Day 2 of Conditioning (1 day post Day 1 of Conditioning) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Effect of oxytocin on learning