NCT02526914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
432

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

August 14, 2015

Last Update Submit

August 16, 2015

Conditions

Healthy

Keywords

social cognitionoxytocinvasopressindecision makingsocial decision makingeconomic games

Outcome Measures

Primary Outcomes (1)

  • Preferences for competitive vs cooperative compensations and monetary allocations as measured by participants monetary allocations and compensation choice

    A group analysis will compare compensations preference (competitive vs. noncompetitive), performance and outcomes and monetary allocations on several economic games between the oxytocin, vasopressin and placebo groups.

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

Secondary Outcomes (9)

  • Redistribution preferences as measured by participants' tax rate determination

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

  • Willingness to compete as measured by participants compensation choice.

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

  • Monetary offers in public goods game

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

  • Bargaining performance as assessed by participants' earnings in bargaining compensation

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

  • Monetary offers in all pay auction

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

  • +4 more secondary outcomes

Study Arms (3)

Intranasal Oxytocin

EXPERIMENTAL

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

Drug: Intranasal Oxytocin

Intranasal vasopressin

EXPERIMENTAL

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

Drug: Intranasal vasopressin

Intranasal placebo

PLACEBO COMPARATOR

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

Drug: Intranasal placebo

Interventions

Intranasal OxytocinDRUG

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).

Also known as: syntocinon
Intranasal Oxytocin
Intranasal vasopressinDRUG

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 vasopressin
Intranasal placeboDRUG

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.

Intranasal placebo

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy controls

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Medical Organization

Jerusalem, Jerusalem, Israel

Location

Related Publications (3)

  • 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.

    PMID: 21852800BACKGROUND

  • 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.

    PMID: 15931222BACKGROUND

  • 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.

    PMID: 23648680BACKGROUND

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • David Mankuta, MD

    Hadassah University Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mankuta, MD

CONTACT

972-2-6776484mankutad@gmail.com

Salomon Israel

CONTACT

972-2-5883401salomon.israel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
David Mankuta, MD

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

IL(1)