Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making

Healthy Clinical Trial

Official title:

Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02526914
• Other study ID #: Hadassah Medical Organization
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2015
• Last updated: August 16, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2015
• Source: Hadassah Medical Organization
• Contact: David Mankuta, MD
• Phone: 972-2-6776484
• Email: mankutad[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 432
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Intranasal Oxytocin
Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).
• Intranasal vasopressin
Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).
• Intranasal placebo
Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: di-sodium hydrogen phosphate, critic acid, sodium chloride, glycerin, benzalkonium chloride and aqua bidest.

Locations

Country	Name	City	State
Israel	Hadassah University Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
David Mankuta	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferences for competitive vs cooperative compensations and monetary allocations as measured by participants monetary allocations and compensation choice	A group analysis will compare compensations preference (competitive vs. noncompetitive), performance and outcomes and monetary allocations on several economic games between the oxytocin, vasopressin and placebo groups.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Redistribution preferences as measured by participants' tax rate determination	Participants will choose redistribution of monetary units by determined tax rate (high vs. low). Each participant gets a different amount of monetary units (ranging from 10 to 150). Using a mixed 2 (above vs. below group mean of monetary units) x 3 (oxytocin, vasopressin, placebo) factorial design, comparisons of these tax rate preference will then be made for those in the oxytocin vs. vasopressin vs. placebo groups. Main effects of drug condition (oxytocin, vasopressin, placebo) and monetary condition (above, below group mean), as well as an interaction between drug condition and monetary condition will be analyzed at a significance level of p<.05.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Willingness to compete as measured by participants compensation choice.	Willingness to compete will be measured by participants' preference whether to compete against other participant for a monetary payment or to get a smaller payment for their non-competitive piece rate performance on maze solving task. We will analyses performance and payment preference (competitive vs. noncompetitive) between oxytocin, vasopressin and placebo at a significance level of p<.05.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Monetary offers in public goods game	Participants in two rival teams will offer monetary units for the right to take part in a lottery (higher team's offer = higher odds to win). Members of each team may, for a monetary cost, impose a tax on their team members. We will compare monetary offers and taxes' impose pattern between oxytocin, vasopressin and placebo groups at a significance level of p<.05 .	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Bargaining performance as assessed by participants' earnings in bargaining compensation	Analysis will compare negotiation outcomes, in terms of monetary units earnings between oxytocin, vasopressin and placebo groups at a significance level of p<.05.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Monetary offers in all pay auction	Analysis will compare participants' monetary offers in multi-participants all-pay auction between oxytocin, vasopressin and placebo groups at a significance level of p<.05.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Negative hypothesis test strategy usage on Wason's-rule-discovery-task after exposure to trustworthy/untrustworthy face	Number of positive hypothesis tests (compare to 'negative-test') out of 6 participants' generated tests. Analysis will compare number of positive tests (vs. negative tests) between oxytocin, vasopressin and placebo groups at a significance level of p<.05.	approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo	No
Secondary	Positive and negative affect scale (PANAS)	Using the Positive and negative affect scale (PANAS) we will measure participants emotional reaction to Oxytocin, vasopressin and placebo. Participants will report their current mood by rate the level they feel 20 different emotions at the moment on a the PANAS scale, ranging from 1 (not at all) to 5 (very much).	approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo	No
Secondary	Fear of negative evaluation (FNE) as measured by self reporting	Participants will report their fear of evaluation by rate how much 12 statements characterize them. participants will use a scale ranging from 1 ("Not at all characteristic me") to 5 ("Extremely characteristic of me").	approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo	No
Secondary	Social value orientation as measured by monetary allocations preferences	Participants will make decisions regarding the allocation of monetary units between themselves and other participants. We will measure the quantity of monetary units kept for themselves vs. given to other participants.	approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo	No