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Completed

NCT Number: NCT02393456

Oxytocin and the Social Brain

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with increased trust, generosity, empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of oxytocin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin on several tasks involving social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning will help to inform research that has begun to establish the potential for use of this neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits.

The investigators hypothesize that compared to placebo, oxytocin will improve deception detection, increase empathy and altruism, and enhance responses to photo stimuli of primary caregivers. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for oxytocin, but rather, analyses of relevant moderators will elucidate these findings.

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Key information

Conditions

Social Psychology

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCLA Department of Psychology

Los Angeles, California, 90095-1563, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-30 years of age
  • Healthy (see below)
  • Fluent in English
  • Right-handed

Exclusion criteria

  • Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
  • Symptoms of runny nose due to allergies/cold or other reason
  • Current restricted fluid intake for any reason
  • Heart disease
  • Hypertension
  • History of myocardial infarction
  • History of cardiac arrhythmia
  • Kidney or liver disease
  • Vascular disease
  • Epilepsy
  • Migraine
  • Asthma
  • Nephritis
  • Diabetes and other endocrine diseases
  • Frequent or unexplained fainting
  • History of stroke
  • Aneurysm or brain hemorrhage
  • Active psychiatric diagnosis
  • Current psychopharmacologic treatment
  • Drug or alcohol abuse
  • Medical or neurological illness
  • Regular use of medication (e.g., vasoconstrictive medications)
  • Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
  • Smoking more than 15 cigarettes a day
  • Consumption of any alcoholic beverages in the past 24 hours will be excluded
  • Elevated blood pressure (>135/90)
  • Low blood pressure (<90/55)
  • Body temperature >100.1 F
  • Left-handed
  • Claustrophobia
  • Presence of metal in their body

Treatment and study plan

Intranasal oxytocin

Drug

Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).

Other names: Syntocinon nasal spray

Intranasal placebo

Drug

Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.

Other names: Glycerine solution

Primary outcomes

  1. Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion

    Time frame: Between 40-115 minutes post administration

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task versus the inclusion portion. A first-level analysis will compare [(friend exclusion>friend inclusion)>(stranger exclusion>stranger inclusion)] for each participant. A second-level group analysis will compare these first-level contrasts between the oxytocin and placebo groups.

Secondary outcomes

  1. Ratings of empathic concern after witnessing social exclusion in a friend or a stranger

    Time frame: Between 40-115 minutes post administration

    Ratings of empathic concern will be calculated for each participant by deriving a composite from self-report ratings of sympathy and compassion. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) as well as the interaction between drug condition and target (friend, stranger) will be analyzed at a significance level of p<.05.

  2. Altruism and punishment as measured by number of points given to excluders and those excluded

    Time frame: Between 40-115 minutes post administration

    Ratings of altruism and punishment will be calculated by examining how many point (1-10) participants decide to allocate towards the friend-excluder, stranger-excluder, excluded friend, and excluded stranger after watching each social exclusion game. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) and target (friend, stranger), as well as an interaction between drug condition and target will be analyzed at a significance level of p<.05.

  3. Changes in neural brain activity, as observed by fMRI, while attempting to detect deception

    Time frame: Between 40-115 minutes post administration

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the deception detection task versus a control task. A first-level analysis will compare deception-detection>control for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.

  4. Accuracy of deception detection as measured by self-report

    Time frame: Between 40-115 minutes post administration

    We will compare the percentage of correct deception detection trials for participants in the oxytocin group to those in the placebo group by running a two-tailed t-test with a statistical cutoff of p<.05 to determine significance.

  5. Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers

    Time frame: Between 40-115 minutes post administration

    Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater while viewing photo stimuli of ones primary caregivers versus viewing photo stimuli of matched strangers. A first-level analysis will compare primary-caregiver-viewing>stranger-viewing for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Oxytocin's Effects on Behavior and Neural Activity During Social Cognition Tasks

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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