Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Positive social relationships have consistently been associated with better health, although the neurobiological underpinnings of these observed effects are not well understood. Valuable insight may be gained by a life course perspective as it is becoming increasingly apparent that early life social experiences are crucially related to later life functioning and well-being. The overall goal of the proposed work is to explore novel biological pathways that help to explain how social relationships influence health. Recent theorizing on the biology relating positive social and emotional factors to health and patterns of resilience suggest that the oxytocin system may underlie some of the observed beneficial effects. Historically, most work on the oxytocin system in humans has been tied to reproductive outcomes (e.g., lactation), with more limited work on children and young adults. A growing body of experimental research with animals suggests that early in life, oxytocin not only creates powerful social bonds between a mother and child but may also stimulate growth and restorative processes as well as buffer deleterious stress-related neuroendocrine activation throughout the life course. Moreover, the animal literature has suggested that oxytocin is more potent in the presence of higher estrogen levels, leading investigators to hypothesize that effects of oxytocin are stronger in women than men, but few studies have tested this hypothesis in humans. A better understanding of the inter-relationships between oxytocin, social relationships, stress, and health will be gained by examining these factors in a controlled laboratory setting. The immediate goal of this research is to determine whether oxytocin plays a critical role in determining neuroendocrine, cardiovascular, and subjective responses to stress across age and gender, and to examine the effects of oxytocin in relation to those of social support. To achieve these goals, experimental research is proposed to examine the effects of exogenously administered (intranasal) oxytocin on psychological and physiological outcomes, under conditions of stress. The specific aims of this exploratory project are to test the following hypotheses:

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 stronger in women versus men.

4. Effects of oxytocin are similar across a range of younger and older adult ages.

Hypotheses will be tested via a placebo-controlled double blind study using a sample of healthy men and women recruited from the community (overall n = 320). The proposed experimental study will consider oxytocin effects on a range of outcomes. These include autonomic reactivity as measured by blood pressure responses and high frequency heart rate variability (measure of vagal tone). Stress-related cardiovascular phenotypes as characterized by the patterning of ventricle contractility, vascular resistance, and cardiac output will also be assessed. Other outcomes include measures of neuroendocrine effects as measured by levels of cortisol and dehydroepiandrosterone (DHEA) hormone, subjective distress and positive affect. Participants will be randomly assigned to receive either exogenous oxytocin or placebo. They will undergo a social stress manipulation with or without social support (randomly assigned), and outcome measures will be obtained at multiple times during the experimental procedure. The experiment will test whether effects of oxytocin and social support are similar and additive, and will also compare effects of oxytocin and social support across men and women of varying ages. This multidisciplinary study uses a biobehavioral framework to examine interactions between psychological, social, and biological levels of functioning, and is informed by theories of how key early life exposures may impact health over the life course. The provision of an R21 award for this work will facilitate novel research that could have a major impact on our understanding of whether and how oxytocin influences responses to stress in humans. The proposed exploratory research will lay the groundwork for the submission of an R01 grant proposal that will have greater resources for addressing both the questions that cannot be addressed with this more limited mechanism as well as new questions that will undoubtedly arise. Ultimately we expect this project will provide a solid platform from which to launch a larger program of research aimed at identifying how positive social and emotional experiences influence adult health and longevity. A neurobiological understanding of resilience can inform efforts for both prevention and intervention of diseases or problems common in later life. ;


Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01011465
Study type Interventional
Source Harvard School of Public Health
Contact
Status Completed
Phase N/A
Start date February 2009
Completion date April 2012

See also
  Status Clinical Trial Phase
Completed NCT02566356 - Adult Study Oxytocin - fMRI Early Phase 1
Completed NCT04330677 - Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin Phase 1
Completed NCT05827731 - Cervical Double Balloon Combined With Oxytocin N/A
Completed NCT02567032 - Adult Study Oxytocin - Behavioral Early Phase 1
Recruiting NCT04760496 - Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour Phase 4
Completed NCT03096249 - The Influence of Oxytocin on Socio-communicative Sensitivity Phase 1/Phase 2
Recruiting NCT05079841 - The Stimulation To Induce Mothers Study Phase 4
Completed NCT05059028 - Effect of Oxytocin Massage and Music on Breastfeeding N/A
Enrolling by invitation NCT06403982 - The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia N/A
Completed NCT03140709 - Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids N/A
Recruiting NCT04109339 - Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy N/A
Completed NCT01891201 - Intrapartum Oxytocin Administration Affects Primitive Neonatal Reflexes N/A
Completed NCT05357521 - Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
Completed NCT03140488 - Oxytocin Dosage to Decrease Induction Duration Phase 4
Completed NCT05823441 - Effect of Oxytocin Nasal Inhalation on Empathy Analgesia Phase 4
Not yet recruiting NCT06010368 - Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section Phase 3
Withdrawn NCT05608070 - IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy Phase 4
Completed NCT04441125 - The Effect of Labor Induction With Oxytocin on Early Postpartum Hemorrhage, Perineal Integrity and Breastfeeding
Recruiting NCT04551482 - Oxytocin for Weight Loss in Adolescents Phase 2
Completed NCT03255148 - Influence of Oxytocin on Resting State Neurophysiological Measures Phase 1