CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Oxytocin +2 moredrug
Likely dose
Oxytocin 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02223429
NCT02223429N/ACompleted

Biological Bases of Individual Variation in Paternal Nurturance

James K. Rilling, PhD·interventional·Posted Aug 22, 2014·Updated Jun 5, 2017

In Brief

A clinical study evaluating Oxytocin, Vasopressin, and 1 other intervention for Healthy. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 22, 2014
Enrollment StartAug 1, 2014
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.9 years ago

Interventions

Oxytocindrug

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

Vasopressindrug

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

Placebodrug

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