Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making

NCT ID: NCT02526914

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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 competition in a healthy population of student controls.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Intranasal Oxytocin

Participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).

Group Type: EXPERIMENTAL

Intranasal Oxytocin

Intervention Type: DRUG

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).

Intranasal vasopressin

Participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).

Group Type: EXPERIMENTAL

Intranasal vasopressin

Intervention Type: DRUG

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).

Intranasal placebo

contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient. Participants will self-administer 5 puffs per nostril.

Group Type: PLACEBO_COMPARATOR

Intranasal placebo

Intervention Type: DRUG

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: di-sodium hydrogen phosphate, critic acid, sodium chloride, glycerin, benzalkonium chloride and aqua bidest.

Interventions

Intranasal Oxytocin

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).

Intervention Type: DRUG

Intranasal vasopressin

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).

Intervention Type: DRUG

Intranasal placebo

Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: di-sodium hydrogen phosphate, critic acid, sodium chloride, glycerin, benzalkonium chloride and aqua bidest.

Intervention Type: DRUG

Other Intervention Names

syntocinon

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

David Mankuta

OTHER

Sponsor Role: lead

Responsible Party

David Mankuta

David Mankuta, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Mankuta, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Medical Organization

Locations

Hadassah University Medical Organization

Jerusalem, Jerusalem, Israel

Countries

Israel

Central Contacts

David Mankuta, MD

Role: CONTACT

mankutad@gmail.com

972-2-6776484

Salomon Israel

Role: CONTACT

salomon.israel@gmail.com

972-2-5883401

Facility Contacts

David Mankuta, MD

Role: primary

mankutad@gmail.com

972-2-6776484

Salomon Israel

Role: backup

salomon.israel@gmail.com

References

Meyer-Lindenberg A, Domes G, Kirsch P, Heinrichs M. Oxytocin and vasopressin in the human brain: social neuropeptides for translational medicine. Nat Rev Neurosci. 2011 Aug 19;12(9):524-38. doi: 10.1038/nrn3044.

Reference Type: BACKGROUND

PMID: 21852800 (View on PubMed)

Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.

Reference Type: BACKGROUND

PMID: 15931222 (View on PubMed)

Veening JG, Olivier B. Intranasal administration of oxytocin: behavioral and clinical effects, a review. Neurosci Biobehav Rev. 2013 Sep;37(8):1445-65. doi: 10.1016/j.neubiorev.2013.04.012. Epub 2013 May 4.

Reference Type: BACKGROUND

PMID: 23648680 (View on PubMed)

Other Identifiers

Hadassah Medical Organization

Identifier Type: -

Identifier Source: org_study_id