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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466127
Recruitment Status : Completed
First Posted : November 7, 2011
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
United States Department of Defense
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Oxytocin Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
Study Start Date : October 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Matched nasal spray placebo.
Drug: Placebo
Matched nasal spray placebo
Experimental: Oxytocin
Liquid intranasal oxytocin administered in a nasal spray.
Drug: Oxytocin
Liquid metered-dose nasal spray, 30 IUs, administered once.
Other Name: Syntocinon

Primary Outcome Measures :
  1. Differential Skin Conductance Response (SCR) During the First Two Extinction Trials [ Time Frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01466127

United States, Massachusetts
Center for Anxiety and Traumatic Disorders, MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
United States Department of Defense
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital

Responsible Party: Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital Identifier: NCT01466127     History of Changes
Other Study ID Numbers: 2010P-002911
First Posted: November 7, 2011    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: March 2017

Keywords provided by Elizabeth A. Hoge, MD, Massachusetts General Hospital:
Effect of oxytocin on learning

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs