HealthyNCT01296269
Effects of Intranasal Oxytocin and Vasopressin on Social Behavior
A study testing Oxytocin and Arginine Vasopressin in people with Healthy, run by Hadassah Medical Organization 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 altruism in a healthy population of student controls. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin and Arginine Vasopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to May 2012
- 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 18 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, 1 recruiting
- Recruiting
Hadassah University Medical Organization
Jerusalem, Jerusalem
David Mankuta, MD, 972-2-6776484, mankutad@gmail.com
Salomon Israel, MA, 972-52-4789754, salomon.israel@mail.huji.ac.il
About this study
Official title: Effects of Intranasal Oxytocin and Vasopressin on Social Behavior in Healthy Controls
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
one-time intranasal administration, 24 International Units, 5 puffs for each nostril
Arginine VasopressinDrug
one-time intranasal administration, 20 International Units, 5 puffs in each nostril
placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin | Experimental | vasopressin condition Receives: Drug: Arginine Vasopressin |
| oxytocin | Experimental | oxytocin condition (syntocinon) Receives: Drug: Oxytocin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
Secondary outcomes (1)
mood as measured via the visual analog scale
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 posted15 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- David Mankuta, MD, Principal investigator, Hadassah University Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296269
- Sponsor's protocol ID
- OXTandAVP-HMO-CTIL
- Status last verified
- Apr 2011
- First submitted
- 3 Feb 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intranasal Oxytocin and Vasopressin on Social Behavior in Healthy Controls
- ClinicalTrials.gov ID
- NCT01296269
- Acronym / sponsor ID
- OXTandAVP-HMO-CTIL
- Conditions
- Healthy
- Keywords
- social cognition, oxytocin, vasopressin, decision making, social decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Apr 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 15 Feb 2011 (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 altruism 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 |
|---|---|---|
| Vasopressin | Experimental | Drug: Arginine Vasopressinvasopressin condition |
| oxytocin | Experimental | Drug: Oxytocinoxytocin condition (syntocinon) |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| OxytocinAlso: syntocinonone-time intranasal administration, 24 International Units, 5 puffs for each nostril | Drug | oxytocin |
| Arginine Vasopressinone-time intranasal administration, 20 International Units, 5 puffs in each nostril | Drug | Vasopressin |
| placebocontains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient, one time intranasal administration, 5 puffs in each nostril | Drug | placebo |
Primary outcome
allocations of monetary units
Time frame: approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo
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
1 secondary outcome
mood as measured via the visual analog scale
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 8 Apr 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Oxytocin and Arginine Vasopressin in people with Healthy, run by Hadassah Medical Organization 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 8 Apr 2011. 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?
allocations of monetary units (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?
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 8 Apr 2011.