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Effects of Intranasal Oxytocin and Vasopressin on Social Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296269
Recruitment Status : Unknown
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : February 15, 2011
Last Update Posted : April 8, 2011
Hebrew University of Jerusalem
Information provided by:
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 altruism in a healthy population of student controls.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxytocin Drug: Arginine Vasopressin Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 in Healthy Controls
Study Start Date : April 2011
Estimated Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vasopressin
vasopressin condition
Drug: Arginine Vasopressin
one-time intranasal administration, 20 International Units, 5 puffs in each nostril

Experimental: oxytocin
oxytocin condition (syntocinon)
Drug: Oxytocin
one-time intranasal administration, 24 International Units, 5 puffs for each nostril
Other Name: syntocinon

Placebo Comparator: placebo Drug: placebo
contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient, one time intranasal administration, 5 puffs in each nostril

Primary Outcome Measures :
  1. allocations of monetary units [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, 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

Secondary Outcome Measures :
  1. mood as measured via the visual analog scale [ Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT01296269

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Contact: David Mankuta, MD 972-2-6776484
Contact: Salomon Israel, MA 972-524789754

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Hadassah University Medical Organization Recruiting
Jerusalem, Israel
Contact: David Mankuta, MD    972-2-6776484   
Contact: Salomon Israel, MA    972-52-4789754   
Principal Investigator: David Mankuta, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
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Principal Investigator: David Mankuta, MD Hadassah University Medical Organization
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Responsible Party: David Mankuta MD, Hadassah Ein-Kerem - obstetrics and gynecology Identifier: NCT01296269    
Other Study ID Numbers: OXTandAVP-HMO-CTIL
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: April 2011
Keywords provided by Hadassah Medical Organization:
social cognition
decision making
social decision making
Additional relevant MeSH terms:
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Arginine Vasopressin
Reproductive Control Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents