HealthyNCT02526914
Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making
A study testing Intranasal Oxytocin and Intranasal vasopressin in people with Healthy, run by David Mankuta at 1 site in Israel.
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 competition in a healthy population of student controls. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal Oxytocin and Intranasal vasopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy controls
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah University Medical Organization
Jerusalem, Jerusalem
David Mankuta, MD, 972-2-6776484, mankutad@gmail.com
Salomon Israel, salomon.israel@gmail.com
About this study
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
- Being tested
- Intranasal Oxytocin, Intranasal vasopressin, Intranasal placebo
- Keywords
- social cognition, oxytocin, vasopressin, decision making, social decision making, economic games
- Medical subject headings
- Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
Also called syntocinon
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 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Experimental | Participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin). Receives: Drug: Intranasal Oxytocin |
| Intranasal vasopressin | Experimental | Participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin). Receives: 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. Receives: Drug: Intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Secondary outcomes (9)
Redistribution preferences as measured by participants' tax rate determination
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.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Willingness to compete as measured by participants compensation choice.
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.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Monetary offers in public goods game
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 .
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Bargaining performance as assessed by participants' earnings in bargaining compensation
Analysis will compare negotiation outcomes, in terms of monetary units earnings between oxytocin, vasopressin and placebo groups at a significance level of p<.05.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Monetary offers in all pay auction
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.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Negative hypothesis test strategy usage on Wason's-rule-discovery-task after exposure to trustworthy/untrustworthy face
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.
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Positive and negative affect scale (PANAS)
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).
Measured: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
Fear of negative evaluation (FNE) as measured by self reporting
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").
Measured: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
Social value orientation as measured by monetary allocations preferences
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.
Measured: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Mankuta
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor-investigator, David Mankuta, Hadassah Medical Organization
- Investigators
- David Mankuta, MD, Principal investigator, Hadassah University Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526914
- Sponsor's protocol ID
- Hadassah Medical Organization
- Status last verified
- Aug 2015
- First submitted
- 14 Aug 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21852800Kosfeld 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.
PubMed 15931222Veening 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.
PubMed 23648680
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin and Vasopressin on Social Behavior and Decision Making
- ClinicalTrials.gov ID
- NCT02526914
- Acronym / sponsor ID
- Hadassah Medical Organization
- Conditions
- Healthy
- Keywords
- social cognition, oxytocin, vasopressin, decision making, social decision making, economic games
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- David MankutaUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Oct 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Experimental | Drug: Intranasal OxytocinParticipants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin). |
| Intranasal vasopressin | Experimental | Drug: Intranasal vasopressinParticipants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin). |
| Intranasal placebo | Placebo comparator | Drug: Intranasal placebocontains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient. Participants will self-administer 5 puffs per nostril. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy controls
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal OxytocinAlso: syntocinonThrough 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). | Drug | Intranasal Oxytocin |
| Intranasal vasopressinThrough 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). | Drug | Intranasal vasopressin |
| Intranasal placeboThrough 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. | Drug | Intranasal placebo |
Primary outcome
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
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.
9 secondary outcomes
Redistribution preferences as measured by participants' tax rate determination
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Willingness to compete as measured by participants compensation choice.
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Monetary offers in public goods game
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Bargaining performance as assessed by participants' earnings in bargaining compensation
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Monetary offers in all pay auction
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
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
Positive and negative affect scale (PANAS)
Time frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
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
Social value orientation as measured by monetary allocations preferences
Time frame: approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Background: PubMed 21852800Meyer-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.
- Background: PubMed 15931222Kosfeld 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.
- Background: PubMed 23648680Veening 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mankuta, MD principal investigator
Hadassah University Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Oxytocin and Intranasal vasopressin in people with Healthy, run by David Mankuta at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Mankuta, MD (972-2-6776484, mankutad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.