Clinical trial NCT01680718: Neuropeptides and Social Behavior
Official title: Neuropeptides and Social Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Social Psychology
Keywords: oxytocin
vasopressin
intranasal administration
healthy sample
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Speed in social working memory task
timeFrame: Between 40-90 minutes post administration
measure: Accuracy of deception detection based on self-report
timeFrame: Between 40-90 minutes post administration
measure: Self-reported perceptions of trust and threat
timeFrame: Between 40-90 minutes post administration
measure: Self-reported empathy and altruistic behavior
timeFrame: Between 40-90 minutes post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Psychology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Naomi I Eisenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.