Oxytocin and Affect Processing in Posttraumatic Stress Disorder
NCT ID: NCT02546570
Last Updated: 2020-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2015-08-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Healthy adult controls (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Oxytocin
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Placebo
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Adults with PTSD (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Oxytocin
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Placebo
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Trauma-exposed/no-PTSD adults (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Oxytocin
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Placebo
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Interventions
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Oxytocin
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Placebo
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Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be in good medical health
* Be cooperative with testing
* English is a language spoken in the family
* PTSD as diagnosed by a certified clinician or the research team for PTSD group.
Exclusion Criteria
* History of hypertension with baseline blood pressure above 160 mm Hg (systolic) over 100 mm Hg (diastolic).
* history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
* weight \>300lb
* The use of some psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
* Currently breast feeding or pregnant
* For MRI ONLY: Any metal or electromagnetic implants
* For MRI ONLY: Significant hearing loss or other severe sensory impairment
* A fragile health status.
* For MRI ONLY: A history of seizures or current use of anticonvulsants
* Healthy adult controls (HC):
* Be free of both neurological and psychiatric disorders (current and past) on the basis of self-report
* Be free of psychiatric disorders
18 Years
55 Years
ALL
Yes
Sponsors
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National Center for PTSD
FED
Yale University
OTHER
Responsible Party
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Principal Investigators
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Linda Mayes, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1502015347
Identifier Type: -
Identifier Source: org_study_id
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