Effects of Intranasal Oxytocin and Vasopressin on Social Behavior

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01296269
• Other study ID #: OXTandAVP-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2011
• Last updated: April 7, 2011
• Start date: April 2011

Study information

• Verified date: April 2011
• Source: Hadassah Medical Organization
• Contact: David Mankuta, MD
• Phone: 972-2-6776484
• Email: mankutad[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Oxytocin
one-time intranasal administration, 24 International Units, 5 puffs for each nostril
• Arginine Vasopressin
one-time intranasal administration, 20 International Units, 5 puffs in each nostril
• 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

Locations

Country	Name	City	State
Israel	Hadassah University Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	allocations of monetary units	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	No
Secondary	mood as measured via the visual analog scale		approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo	No