Effects of Intranasal Oxytocin and Vasopressin on Social Behavior

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01296269
First received: February 3, 2011
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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 Intervention
Healthy
Drug: Oxytocin
Drug: Arginine Vasopressin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Effects of Intranasal Oxytocin and Vasopressin on Social Behavior in Healthy Controls

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • allocations of monetary units [ Time Frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo ] [ Designated as safety issue: No ]
    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:
  • mood as measured via the visual analog scale [ Time Frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296269

Contacts
Contact: David Mankuta, MD 972-2-6776484 mankutad@gmail.com
Contact: Salomon Israel, MA 972-524789754 salomon.israel@mail.huji.ac.il

Locations
Israel
Hadassah University Medical Organization Recruiting
Jerusalem, Israel
Contact: David Mankuta, MD    972-2-6776484    mankutad@gmail.com   
Contact: Salomon Israel, MA    972-52-4789754    salomon.israel@mail.huji.ac.il   
Principal Investigator: David Mankuta, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
Investigators
Principal Investigator: David Mankuta, MD Hadassah University Medical Organization
  More Information

No publications provided

Responsible Party: David Mankuta MD, Hadassah Ein-Kerem - obstetrics and gynecology
ClinicalTrials.gov Identifier: NCT01296269     History of Changes
Other Study ID Numbers: OXTandAVP-HMO-CTIL
Study First Received: February 3, 2011
Last Updated: April 7, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
social cognition
oxytocin
vasopressin
decision making
social decision making

Additional relevant MeSH terms:
Arginine Vasopressin
Vasopressins
Oxytocin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 20, 2014