Oxytocin and the Social Brain

Social Psychology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393456
• Other study ID #: 11-003565-2
• Status: Completed
• Phase: Early Phase 1
• First received: January 22, 2015
• Last updated: August 8, 2017
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Social Psychology

Intervention

Drug:
• Intranasal oxytocin
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).
• Intranasal placebo
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.

Locations

Country	Name	City	State
United States	UCLA Department of Psychology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ratings of empathic concern after witnessing social exclusion in a friend or a stranger	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.	Between 40-115 minutes post administration
Secondary	Altruism and punishment as measured by number of points given to excluders and those excluded	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.	Between 40-115 minutes post administration
Secondary	Changes in neural brain activity, as observed by fMRI, while attempting to detect deception	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.	Between 40-115 minutes post administration
Secondary	Accuracy of deception detection as measured by self-report	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.	Between 40-115 minutes post administration
Secondary	Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers	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.	Between 40-115 minutes post administration