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

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Drug: Oxytocin
Drug: Placebo

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01466127
2010P-002911

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Matched nasal spray placebo.
Treatment:
Drug: Placebo
Oxytocin
Experimental group
Description:
Liquid intranasal oxytocin administered in a nasal spray.
Treatment:
Drug: Oxytocin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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