Neuropeptides and Social Behavior

This study is currently recruiting participants.
Verified October 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Naomi Eisenberger, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01680718
First received: August 31, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Social Psychology
Drug: Intranasal oxytocin
Drug: Intranasal vasopressin
Drug: Intranasal placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Neuropeptides and Social Behavior

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Speed in social working memory task [ Time Frame: Between 40-90 minutes post administration ] [ Designated as safety issue: No ]
    Between group differences in the amount of time it takes to perform tasks involving social working memory

  • Accuracy of deception detection based on self-report [ Time Frame: Between 40-90 minutes post administration ] [ Designated as safety issue: No ]
    Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others

  • Self-reported perceptions of trust and threat [ Time Frame: Between 40-90 minutes post administration ] [ Designated as safety issue: No ]
    Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance

  • Self-reported empathy and altruistic behavior [ Time Frame: Between 40-90 minutes post administration ] [ Designated as safety issue: No ]
    Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal oxytocin
Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
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).
Other Name: Syntocinon nasal spray
Experimental: Intranasal vasopressin
Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
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).
Placebo Comparator: 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.
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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680718

Contacts
Contact: Benjamin A Tabak, PhD btabak@psych.ucla.edu

Locations
United States, California
UCLA Department of Psychology Recruiting
Los Angeles, California, United States, 90095-1563
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Naomi I Eisenberger, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Naomi Eisenberger, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01680718     History of Changes
Other Study ID Numbers: Behavioral Neuropeptides
Study First Received: August 31, 2012
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
oxytocin
vasopressin
intranasal administration
healthy sample

Additional relevant MeSH terms:
Vasopressins
Arginine Vasopressin
Oxytocin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 23, 2014