Neuropeptides and Social Behavior

Social Psychology Clinical Trial

Official title:

Neuropeptides and Social Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680718
• Other study ID #: Behavioral Neuropeptides
• Status: Completed
• Phase: Phase 0
• First received: August 31, 2012
• Last updated: May 27, 2015
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

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 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).
• 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).

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	Speed in social working memory task	Between group differences in the amount of time it takes to perform tasks involving social working memory	Between 40-90 minutes post administration	No
Primary	Accuracy of deception detection based on self-report	Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others	Between 40-90 minutes post administration	No
Primary	Self-reported perceptions of trust and threat	Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance	Between 40-90 minutes post administration	No
Primary	Self-reported empathy and altruistic behavior	Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.	Between 40-90 minutes post administration	No