Clinical trial NCT02526914: Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making
Official title: Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: social cognition
oxytocin
vasopressin
decision making
social decision making
economic games
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2015-08-18
Enrollment: 432
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the role of a one-time intranasal administration of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and competition in a healthy population of student controls.


Eligibility criteria: Inclusion Criteria:

• healthy controls

Exclusion Criteria:

* Past or present psychiatric, neurological, endocrinological or severe chronic medical illness.
* Use of medications or drugs that would interfere with study results. This includes steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous.
* history of drug or alcohol addiction
* Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. All females will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.

Primary outcomes:
measure: Preferences for competitive vs cooperative compensations and monetary allocations as measured by participants monetary allocations and compensation choice
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Secondary outcomes:
measure: Redistribution preferences as measured by participants' tax rate determination
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Willingness to compete as measured by participants compensation choice.
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Monetary offers in public goods game
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Bargaining performance as assessed by participants' earnings in bargaining compensation
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Monetary offers in all pay auction
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Negative hypothesis test strategy usage on Wason's-rule-discovery-task after exposure to trustworthy/untrustworthy face
timeFrame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
measure: Positive and negative affect scale (PANAS)
timeFrame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
measure: Fear of negative evaluation (FNE) as measured by self reporting
timeFrame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
measure: Social value orientation as measured by monetary allocations preferences
timeFrame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Medical Organization
Study officials:
affiliation: Hadassah University Medical Organization
name: David Mankuta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer-Lindenberg A, Domes G, Kirsch P, Heinrichs M. Oxytocin and vasopressin in the human brain: social neuropeptides for translational medicine. Nat Rev Neurosci. 2011 Aug 19;12(9):524-38. doi: 10.1038/nrn3044.
citation: Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
citation: Veening JG, Olivier B. Intranasal administration of oxytocin: behavioral and clinical effects, a review. Neurosci Biobehav Rev. 2013 Sep;37(8):1445-65. doi: 10.1016/j.neubiorev.2013.04.012. Epub 2013 May 4.