Oxytocin and the Social Brain

NCT02393456 | Completed Early Phase 1 DMC

• 1 other identifier: 11-003565-2
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Psychology

Outcome Measures

Primary Outcomes (1)

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

  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.

  Between 40-115 minutes post administration

Secondary Outcomes (5)

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

  Between 40-115 minutes post administration

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

  Between 40-115 minutes post administration

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

  Between 40-115 minutes post administration

• Accuracy of deception detection as measured by self-report

  Between 40-115 minutes post administration

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

  Between 40-115 minutes post administration

Study Arms (2)

Intranasal oxytocin

EXPERIMENTAL

Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).

Drug: Intranasal oxytocin

Intranasal placebo

PLACEBO COMPARATOR

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. Participants will self-administer 5 puffs per nostril.

Drug: Intranasal placebo

Interventions

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).

Also known as: Syntocinon nasal spray

Intranasal oxytocin

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.

Also known as: Glycerine solution

Intranasal placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Department of Psychology

Los Angeles, California, 90095-1563, United States

Location

Related Publications (1)

• Straccia MA, Teed AR, Katzman PL, Tan KM, Parrish MH, Irwin MR, Eisenberger NI, Lieberman MD, Tabak BA. Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial. Psychol Med. 2023 Apr;53(6):2285-2295. doi: 10.1017/S0033291721004104. Epub 2021 Oct 15.

  PMID: 37310308 DERIVED

Study Officials

• Matthew D Lieberman, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matthew D. Lieberman, PhD

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: March 19, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

US (1)