Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT01296269
Status:
UNKNOWN
Last Update Posted:
2011-04-08
First Post:
2011-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intranasal Oxytocin and Vasopressin on Social Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D001127', 'term': 'Arginine Vasopressin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2011-02-14', 'lastUpdatePostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'allocations of monetary units', 'timeFrame': 'approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo', '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'}], 'secondaryOutcomes': [{'measure': 'mood as measured via the visual analog scale', 'timeFrame': 'approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['social cognition', 'oxytocin', 'vasopressin', 'decision making', 'social decision making'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy controls\n\nExclusion Criteria:\n\n* Past or present psychiatric, neurological, endocrinological or severe chronic medical illness.\n* 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.\n* history of drug or alcohol addiction\n* 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.'}, 'identificationModule': {'nctId': 'NCT01296269', 'briefTitle': 'Effects of Intranasal Oxytocin and Vasopressin on Social Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Effects of Intranasal Oxytocin and Vasopressin on Social Behavior in Healthy Controls', 'orgStudyIdInfo': {'id': 'OXTandAVP-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vasopressin', 'description': 'vasopressin condition', 'interventionNames': ['Drug: Arginine Vasopressin']}, {'type': 'EXPERIMENTAL', 'label': 'oxytocin', 'description': 'oxytocin condition (syntocinon)', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['syntocinon'], 'description': 'one-time intranasal administration, 24 International Units, 5 puffs for each nostril', 'armGroupLabels': ['oxytocin']}, {'name': 'Arginine Vasopressin', 'type': 'DRUG', 'description': 'one-time intranasal administration, 20 International Units, 5 puffs in each nostril', 'armGroupLabels': ['Vasopressin']}, {'name': 'placebo', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'state': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David Mankuta, MD', 'role': 'CONTACT', 'email': 'mankutad@gmail.com', 'phone': '972-2-6776484'}, {'name': 'Salomon Israel, MA', 'role': 'CONTACT', 'email': 'salomon.israel@mail.huji.ac.il', 'phone': '972-52-4789754'}, {'name': 'David Mankuta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah University Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'David Mankuta, MD', 'role': 'CONTACT', 'email': 'mankutad@gmail.com', 'phone': '972-2-6776484'}, {'name': 'Salomon Israel, MA', 'role': 'CONTACT', 'email': 'salomon.israel@mail.huji.ac.il', 'phone': '972-524789754'}], 'overallOfficials': [{'name': 'David Mankuta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah University Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebrew University of Jerusalem', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'David Mankuta MD', 'oldOrganization': 'Hadassah Ein-Kerem - obstetrics and gynecology'}}}}