- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01680718
Neuropeptides and Social Behavior
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90095-1563
- UCLA Department of Psychology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intranasal oxytocin
Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU 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 Names:
|
|
EXPERIMENTAL: Intranasal vasopressin
Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speed in social working memory task
Time Frame: Between 40-90 minutes post administration
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Between group differences in the amount of time it takes to perform tasks involving social working memory
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Between 40-90 minutes post administration
|
|
Accuracy of deception detection based on self-report
Time Frame: Between 40-90 minutes post administration
|
Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others
|
Between 40-90 minutes post administration
|
|
Self-reported perceptions of trust and threat
Time Frame: Between 40-90 minutes post administration
|
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
|
|
Self-reported empathy and altruistic behavior
Time Frame: Between 40-90 minutes post administration
|
Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.
|
Between 40-90 minutes post administration
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Behavioral Neuropeptides
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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