CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 270 enrolled
Drug / intervention
intranasal oxytocin +3 moredrug
Likely dose
intranasal oxytocin 10 mlfrom record
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Search/NCT01011465
NCT01011465N/ACompleted

The Biology of Resilience: Oxytocin, Social Relationships and Health

Harvard School of Public Health (HSPH)·interventional·Posted Nov 11, 2009·Updated Nov 26, 2012

In Brief

A clinical study evaluating intranasal oxytocin, Placebo, and 2 other interventions for Oxytocin and Placebo. Completed, enrolled 270 participants across 1 site.

Detailed Summary

Positive social relationships have consistently been associated with better health, although the neurobiological underpinnings of these observed effects remain largely unknown. The overall goal of the proposed work is to explore novel biological pathways that may explain how social relationships influence health. Recent theorizing suggests that the oxytocin system may underlie some of the observed beneficial effects. Four hypotheses will be examined: 1. Oxytocin ameliorates the deleterious neuroendocrine, cardiovascular, and subjective effects of stress. 2. Oxytocin and social support have similar and additive stress-buffering effects. 3. Effects of oxytocin are evident among younger and older adults. 4. Effects of oxytocin are stronger in women vs men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOxytocin, Placebo
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartFeb 1, 2009
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.6 years ago

Interventions

intranasal oxytocindrug

The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after 24 IUs of oxytocin have been administered. Duration of administration is anticipated to be 2-5 minutes

Placebodrug

Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo will be administered at one time only during the procedure. Approximately half the dose will be sprayed into each nostril. Administration will stop after the full amount in the spray bottle has been used. Duration of administration is anticipated to be 2-5 minutes

Social supportbehavioral

Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. If instructed to bring a same-sex close friend (excluding spouses, participants are joined by their support partners join participants at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.

No Social Supportbehavioral

Prior to coming to the laboratory, participants are randomly assigned to one of two conditions, requiring them to appear alone or accompanied by a partner. They are then instructed to bring a same-sex close friend (excluding spouses) with them, or to come alone. If they come to the laboratory without a friend, they engage in all the laboratory procedures without a friend present.