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

November 2, 2011
April 7, 2014
October 2011
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01466127 on ClinicalTrials.gov Archive Site
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The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Posttraumatic Stress Disorder
  • Drug: Oxytocin
    Liquid metered-dose nasal spray, 30 IUs, administered once.
    Other Name: Syntocinon
  • Drug: Placebo
    Matched nasal spray placebo
  • Placebo Comparator: Placebo
    Matched nasal spray placebo.
    Intervention: Drug: Placebo
  • Experimental: Oxytocin
    Liquid intranasal oxytocin administered in a nasal spray.
    Intervention: Drug: Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Not Provided
United States
 
NCT01466127
2010P-002911
No
Elizabeth A. Hoge, MD, Massachusetts General Hospital
Massachusetts General Hospital
Department of Defense
Principal Investigator: Elizabeth A Hoge, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP