Oxytocin and the Social Brain

NCT ID: NCT02393456

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intranasal oxytocin

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

Group Type: EXPERIMENTAL

Intranasal oxytocin

Intervention Type: 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).

Intranasal placebo

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.

Group Type: PLACEBO_COMPARATOR

Intranasal placebo

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Syntocinon nasal spray; Glycerine solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Matthew Lieberman

Matthew D. Lieberman, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew D Lieberman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Department of Psychology

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37310308 (View on PubMed)

Other Identifiers

11-003565-2

Identifier Type: -

Identifier Source: org_study_id