Neuropeptides and Social Behavior

NCT ID: NCT01680718

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-09-30

Brief Summary

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, we 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 and vasopressin, neuropeptides that are naturally produced in the hypothalamus, because administration of these neuropeptides 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 and vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin and vasopressin on social working memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic behavior. Understanding how oxytocin and vasopressin influence these aspects of social functioning will help to inform research that has begun to establish the potential for use of these neuropeptides in psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits. For this study, we will recruit 150 healthy adults without a history of medical or psychiatric illness to come to the laboratory. In the first session, participants will complete several questionnaires. In the second session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo. The study nurses will measure temperature, heart rate, and blood pressure (female participants will also be asked to undergo a pregnancy test) before drug administration. Participants will then complete computer tasks. During the second session, we will also collect a saliva sample for genetic analysis and participants will be asked to complete several additional questionnaires. At the end of the experimental session, participants will be fully debriefed.

The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will improve social working memory and deception detection, and increase empathy and altruism. It is also hypothesized that main effects will not be found for oxytocin or vasopressin, but rather, analyses of relevant moderators will elucidate these findings.

Conditions

Social Psychology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• 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 vasopressin

Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).

Group Type: EXPERIMENTAL

Intranasal vasopressin

Intervention Type: DRUG

Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).

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 (used previously; Bartz et al., 2010). 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 (used previously; Bartz et al., 2010).

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 vasopressin

Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).

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 (used previously; Bartz et al., 2010).

Intervention Type: DRUG

Other Intervention Names

Syntocinon nasal spray

Eligibility Criteria

Inclusion Criteria

• 18-50 years of age
• Healthy (see below)
• Fluent in English

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 (>130/90)
• Low blood pressure (<90/60)
• Body temperature >100.1 F

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Naomi Eisenberger

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naomi I Eisenberger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Department of Psychology

Los Angeles, California, United States

Countries

United States

References

Tabak BA, Teed AR, Castle E, Dutcher JM, Meyer ML, Bryan R, Irwin MR, Lieberman MD, Eisenberger NI. Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial. Psychoneuroendocrinology. 2019 Sep;107:124-132. doi: 10.1016/j.psyneuen.2019.04.019. Epub 2019 Apr 29.

Reference Type: DERIVED

PMID: 31128568 (View on PubMed)

Tabak BA, Meyer ML, Dutcher JM, Castle E, Irwin MR, Lieberman MD, Eisenberger NI. Oxytocin, but not vasopressin, impairs social cognitive ability among individuals with higher levels of social anxiety: a randomized controlled trial. Soc Cogn Affect Neurosci. 2016 Aug;11(8):1272-9. doi: 10.1093/scan/nsw041. Epub 2016 Apr 6.

Reference Type: DERIVED

PMID: 27053769 (View on PubMed)

Tabak BA, Meyer ML, Castle E, Dutcher JM, Irwin MR, Han JH, Lieberman MD, Eisenberger NI. Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial. Psychoneuroendocrinology. 2015 Jan;51:253-61. doi: 10.1016/j.psyneuen.2014.10.006. Epub 2014 Oct 17.

Reference Type: DERIVED

PMID: 25462898 (View on PubMed)

Other Identifiers

Behavioral Neuropeptides

Identifier Type: -

Identifier Source: org_study_id