Effects of Intranasal Oxytocin and Vasopressin on Social Behavior

April 7, 2011 updated by: Hadassah Medical Organization

Effects of Intranasal Oxytocin and Vasopressin on Social Behavior in Healthy Controls

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah University Medical Organization
        • Principal Investigator:
          • David Mankuta, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
mood as measured via the visual analog scale
Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Hebrew University of Jerusalem

Investigators

  • Principal Investigator: David Mankuta, MD, Hadassah University Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXTandAVP-HMO-CTIL

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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