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

This study is currently recruiting participants.
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth A. Hoge, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01466127
First received: November 2, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Drug: Oxytocin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Physiological reactivity as measured by skin conductance, heart rate, and corrugator EMG [ Time Frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning) ] [ Designated as safety issue: No ]
    Differences in physiological reactivity between the active vs. placebo conditions will be used to assess for the impact of oxytocin on fear renewal and reinstatement.


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women 18 to 65 years of age
  • Score in study range on the NEO-FFI
  • No current Axis I DSM-IV excluded diagnoses as determined by the 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466127

Locations
United States, Massachusetts
Center for Anxiety and Traumatic Disorders, MGH Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rebecca Ojserkis    617-724-0851    rojserkis@partners.org   
Principal Investigator: Elizabeth A Hoge, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth A. Hoge, MD, Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01466127     History of Changes
Other Study ID Numbers: 2010P-002911
Study First Received: November 2, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Effect of oxytocin on learning

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014