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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
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
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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
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 May 23, 2013