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

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ClinicalTrials.gov Identifier: NCT02526914
Recruitment Status : Unknown
Verified August 2015 by David Mankuta, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 18, 2015
Last Update Posted : August 18, 2015
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
David Mankuta, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Intranasal Oxytocin Drug: Intranasal vasopressin Drug: Intranasal placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making
Study Start Date : October 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intranasal Oxytocin
Participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).
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).
Other Name: syntocinon

Experimental: Intranasal vasopressin
Participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).
Drug: 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).

Placebo Comparator: Intranasal placebo
contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient. Participants will self-administer 5 puffs per nostril.
Drug: 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.




Primary Outcome Measures :
  1. Preferences for competitive vs cooperative compensations and monetary allocations as measured by participants monetary allocations and compensation choice [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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.


Secondary Outcome Measures :
  1. Redistribution preferences as measured by participants' tax rate determination [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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.

  2. Willingness to compete as measured by participants compensation choice. [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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.

  3. Monetary offers in public goods game [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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 .

  4. Bargaining performance as assessed by participants' earnings in bargaining compensation [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    Analysis will compare negotiation outcomes, in terms of monetary units earnings between oxytocin, vasopressin and placebo groups at a significance level of p<.05.

  5. Monetary offers in all pay auction [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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.

  6. Negative hypothesis test strategy usage on Wason's-rule-discovery-task after exposure to trustworthy/untrustworthy face [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ]
    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.

  7. Positive and negative affect scale (PANAS) [ Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo ]
    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).

  8. Fear of negative evaluation (FNE) as measured by self reporting [ Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo ]
    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").

  9. Social value orientation as measured by monetary allocations preferences [ Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo ]
    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.



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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526914


Contacts
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Contact: David Mankuta, MD 972-2-6776484 mankutad@gmail.com
Contact: Salomon Israel 972-2-5883401 salomon.israel@gmail.com

Locations
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Israel
Hadassah University Medical Organization
Jerusalem, Israel
Contact: David Mankuta, MD    972-2-6776484    mankutad@gmail.com   
Contact: Salomon Israel       salomon.israel@gmail.com   
Principal Investigator: David Mankuta, MD         
Sponsors and Collaborators
David Mankuta
Hebrew University of Jerusalem
Investigators
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Principal Investigator: David Mankuta, MD Hadassah University Medical Organization
Publications:
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Responsible Party: David Mankuta, David Mankuta, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02526914    
Other Study ID Numbers: Hadassah Medical Organization
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by David Mankuta, Hadassah Medical Organization:
social cognition
oxytocin
vasopressin
decision making
social decision making
economic games
Additional relevant MeSH terms:
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Vasopressins
Arginine Vasopressin
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents