Oxytocin and Affect Processing in Posttraumatic Stress Disorder

NCT ID: NCT02546570

Last Updated: 2020-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-08-31

Brief Summary

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The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD).

Detailed Description

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The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD). The investigators expect oxytocin (compared to placebo) to positively influence affect processing in healthy subjects, as well as among those diagnosed with PTSD. Given current literature, the investigators expect oxytocin to elevate the processing\\perception of positive-related stimuli, and reduce the salience of aversive or un-pleasant cues. The investigators expect oxytocin to impact participants' brain function as measured with functional magnetic resonance imaging (fMRI) while visually processing social and affect-related stimuli, rendering brain function and affective processing to be "more typical" or "adaptive" compared to placebo. Oxytocin's effect on human repertoire is not necessarily direct, but can interact with the individual's socioemotional characteristics, early life environment, and psychiatric symptoms. Therefore, the investigators will incorporate measures that capture the various dimensions that likely shape the effect of oxytocin.

Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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).

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

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Placebo

Intervention Type DRUG

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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).

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

See arm/group descriptions for dosage amount and procedure.

Placebo

Intervention Type DRUG

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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).

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

See arm/group descriptions for dosage amount and procedure.

Placebo

Intervention Type DRUG

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Interventions

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Oxytocin

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Intervention Type DRUG

Placebo

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Intervention Type DRUG

Other Intervention Names

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Pitocin saline

Eligibility Criteria

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Inclusion Criteria

* Adults: age 18-55
* 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

* Moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes, epilepsy, influenza).
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for PTSD

FED

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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1502015347

Identifier Type: -

Identifier Source: org_study_id

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