Neurobiological Bases of Paternal Nurturance

NCT ID: NCT02223429

Last Updated: 2017-06-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-02-29

Brief Summary

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The overall goal of this project is to identify the genetic, hormonal, and neurobiological influences on paternal nurturing behavior and to determine if fathers' neural responses to infants can be modulated by neuropeptides known to play a role in parenting in experimental animal models.

The aim is to determine if pharmacological manipulation of central oxytocin (OT) and vasopressin (AVP) levels influences the neural response to viewing pictures of one's own infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old children will be scanned on two separate occasions; once under the influence of OT/AVP and once under the influence of placebo. Fathers will be randomized to either OT or AVP, and order of administration of drug and placebo will counterbalanced across subjects. Fathers will be scanned while viewing pictures of their own and an unknown child and while listening to unknown infant cry stimuli.

The investigators hypothesize:

* OT will augment the ventral tegmental area (VTA), ventral striatum and medial orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will augment the primary auditory cortex (AI) response of fathers to infant cries.
* AVP will augment the lateral septum response to viewing own child pictures.

Detailed Description

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30 fathers of children aged 1-3 will participate in two functional imaging sequence (fMRI) sessions, once under the influence of OT/AVP, and once under the influence of placebo. Fathers will be restricted to men who are living with their biological child and an adult partner (male or female) that they are in a committed relationship with. All fathers will receive two fMRI scans on two different occasions, separated by 2-10 days. 15 fathers will be randomized to intranasal OT, the other 15 will be randomized to intranasal AVP. Within each drug group, the order of administration of drug and placebo will counterbalanced across subjects, such that 15 will receive OT/AVP first, and 15 will receive OT/AVP second. During the fMRI scans, fathers will view pictures of their own and unknown children, as well as unknown adults. Afterwards, while still in the scanner, they will listen to infant cry and control stimuli. After exiting the scanner, fathers will again listen to the cry stimuli and will rate their emotional reaction to the cry stimuli on the following dimensions using a 7 point likert scale: irritated, sympathetic, alarmed, angry, upset, compassionate, distressed, annoyed, and tender.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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OT + placebo

The OT + placebo group will self-administer no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive OT first, and half will receive OT second.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Placebo

Intervention Type DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

AVP + placebo

The AVP + placebo group will self-administer no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive AVP first, and half will receive AVP second.

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Placebo

Intervention Type DRUG

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Interventions

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Oxytocin

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Intervention Type DRUG

Vasopressin

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Intervention Type DRUG

Placebo

1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays

Intervention Type DRUG

Other Intervention Names

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Pitocin Syntocinon OT Argipressin Arginine vasopressin (AVP) Antidiuretic hormone (ADH)

Eligibility Criteria

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Inclusion Criteria

* above 18
* biological fathers of 1-3 year old infants who are currently cohabitating with the child's mother
* normal or corrected-to-normal vision of 20/40

Exclusion Criteria

* current or past history of mental illness
* active medical or neurological disorder
* current or past history of alcohol or drug dependence
* claustrophobic (at the discretion of the PI with subject consultation)
* history of seizures or other neurological disorder
* history of hypertension, cardiovascular disease, nephritis, diabetes or other endocrine diseases or malignancy
* ferrous metal in any part of the body
* history of asthma or migraine headaches (can be included at the discretion of the study physician or nurse practitioner if episodes are infrequent and no active problems at time of study, not medicated)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

James K. Rilling, PhD

OTHER

Sponsor Role lead

Responsible Party

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James K. Rilling, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James K Rilling, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Emory University 1462 Clifton Rd

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Hamann S, Herman RA, Nolan CL, Wallen K. Men and women differ in amygdala response to visual sexual stimuli. Nat Neurosci. 2004 Apr;7(4):411-6. doi: 10.1038/nn1208. Epub 2004 Mar 7.

Reference Type BACKGROUND
PMID: 15004563 (View on PubMed)

Related Links

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Other Identifiers

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R21HD078778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00044782

Identifier Type: -

Identifier Source: org_study_id

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