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Trial · Interventional

Status unknownNot applicableRegistry data

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

NCTNCT02526914 (opens ClinicalTrials.gov in a new tab)Other idHadassah Medical Organization
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
432 participants (estimated)
Sponsor
David Mankuta · Other
Design
Randomized · Double masking
Countries
1 country

Israel

Start
Oct 2015
Primary completion
Jul 2017 (estimated)
Completion
Oct 2017 (estimated)
First posted
18 Aug 2015 (estimated)
Last update posted
18 Aug 2015 (estimated)
Conditions
Healthy

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. N/A

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

    NCT02526914

    Oct 2015 to est. Oct 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Intranasal OxytocinDrug
  • Intranasal vasopressinDrug
  • Intranasal placeboDrug

Arms3

  • Experimental

    Intranasal Oxytocin

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

  • Experimental

    Intranasal vasopressin

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

  • Placebo comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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.

Secondary outcomes(9)

  1. Redistribution preferences as measured by participants' tax rate determination

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

    Registry description

    Participants will choose redistribution of monetary units by determined tax rate (high vs. low). Each participant gets a different amount of monetary units (ranging from 10 to 150). Using a mixed 2 (above vs. below group mean of monetary units) x 3 (oxytocin, vasopressin, placebo) factorial design, comparisons of these tax rate preference will then be made for those in the oxytocin vs. vasopressin vs. placebo groups. Main effects of drug condition (oxytocin, vasopressin, placebo) and monetary condition (above, below group mean), as well as an interaction between drug condition and monetary condition will be analyzed at a significance level of p\<.05.

  2. Willingness to compete as measured by participants compensation choice.

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

    Registry description

    Willingness to compete will be measured by participants' preference whether to compete against other participant for a monetary payment or to get a smaller payment for their non-competitive piece rate performance on maze solving task. We will analyses performance and payment preference (competitive vs. noncompetitive) between oxytocin, vasopressin and placebo at a significance level of p\<.05.

  3. Monetary offers in public goods game

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

    Registry description

    Participants in two rival teams will offer monetary units for the right to take part in a lottery (higher team's offer = higher odds to win). Members of each team may, for a monetary cost, impose a tax on their team members. We will compare monetary offers and taxes' impose pattern between oxytocin, vasopressin and placebo groups at a significance level of p\<.05 .

  4. Bargaining performance as assessed by participants' earnings in bargaining compensation

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

    Registry description

    Analysis will compare negotiation outcomes, in terms of monetary units earnings between oxytocin, vasopressin and placebo groups at a significance level of p\<.05.

  5. Monetary offers in all pay auction

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

    Registry description

    Analysis will compare participants' monetary offers in multi-participants all-pay auction between oxytocin, vasopressin and placebo groups at a significance level of p\<.05.

  6. Negative hypothesis test strategy usage on Wason's-rule-discovery-task after exposure to trustworthy/untrustworthy face

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

    Registry description

    Number of positive hypothesis tests (compare to 'negative-test') out of 6 participants' generated tests. Analysis will compare number of positive tests (vs. negative tests) between oxytocin, vasopressin and placebo groups at a significance level of p\<.05.

  7. Positive and negative affect scale (PANAS)

    Time frame · approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo

    Registry description

    Using the Positive and negative affect scale (PANAS) we will measure participants emotional reaction to Oxytocin, vasopressin and placebo. Participants will report their current mood by rate the level they feel 20 different emotions at the moment on a the PANAS scale, ranging from 1 (not at all) to 5 (very much).

  8. Fear of negative evaluation (FNE) as measured by self reporting

    Time frame · approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo

    Registry description

    Participants will report their fear of evaluation by rate how much 12 statements characterize them. participants will use a scale ranging from 1 ("Not at all characteristic me") to 5 ("Extremely characteristic of me").

  9. Social value orientation as measured by monetary allocations preferences

    Time frame · approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

2 studies on this page

Indexing hint: Review · 2013

Intranasal administration of oxytocin: behavioral and clinical effects, a review.

Veening et al. 2013Neuroscience and biobehavioral reviewscited by 140

PMID 23648680PMC7112651DOI 10.1016/j.neubiorev.2013.04.012PUB-23648680

Rights unknown
Source link

Indexing hint: Review · 2011

Oxytocin and vasopressin in the human brain: social neuropeptides for translational medicine.

Meyer-Lindenberg et al. 2011Nature reviews. Neurosciencecited by 1,262

PMID 21852800DOI 10.1038/nrn3044PUB-21852800

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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