Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-01-17 @ 3:45 AM
Study NCT ID:
NCT01680718
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropeptides and 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed in social working memory task', 'timeFrame': 'Between 40-90 minutes post administration', 'description': 'Between group differences in the amount of time it takes to perform tasks involving social working memory'}, {'measure': 'Accuracy of deception detection based on self-report', 'timeFrame': 'Between 40-90 minutes post administration', 'description': 'Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others'}, {'measure': 'Self-reported perceptions of trust and threat', 'timeFrame': 'Between 40-90 minutes post administration', 'description': 'Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance'}, {'measure': 'Self-reported empathy and altruistic behavior', 'timeFrame': 'Between 40-90 minutes post administration', 'description': 'Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oxytocin', 'vasopressin', 'intranasal administration', 'healthy sample'], 'conditions': ['Social Psychology']}, 'referencesModule': {'references': [{'pmid': '31128568', 'type': 'DERIVED', 'citation': 'Tabak BA, Teed AR, Castle E, Dutcher JM, Meyer ML, Bryan R, Irwin MR, Lieberman MD, Eisenberger NI. Null results of oxytocin and vasopressin administration across a range of social cognitive and behavioral paradigms: Evidence from a randomized controlled trial. Psychoneuroendocrinology. 2019 Sep;107:124-132. doi: 10.1016/j.psyneuen.2019.04.019. Epub 2019 Apr 29.'}, {'pmid': '27053769', 'type': 'DERIVED', 'citation': 'Tabak BA, Meyer ML, Dutcher JM, Castle E, Irwin MR, Lieberman MD, Eisenberger NI. Oxytocin, but not vasopressin, impairs social cognitive ability among individuals with higher levels of social anxiety: a randomized controlled trial. Soc Cogn Affect Neurosci. 2016 Aug;11(8):1272-9. doi: 10.1093/scan/nsw041. Epub 2016 Apr 6.'}, {'pmid': '25462898', 'type': 'DERIVED', 'citation': 'Tabak BA, Meyer ML, Castle E, Dutcher JM, Irwin MR, Han JH, Lieberman MD, Eisenberger NI. Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial. Psychoneuroendocrinology. 2015 Jan;51:253-61. doi: 10.1016/j.psyneuen.2014.10.006. Epub 2014 Oct 17.'}]}, 'descriptionModule': {'briefSummary': "It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, we are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on oxytocin and vasopressin, neuropeptides that are naturally produced in the hypothalamus, because administration of these neuropeptides has been associated with increased trust, generosity, empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of oxytocin and vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin and vasopressin on social working memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic behavior. Understanding how oxytocin and vasopressin influence these aspects of social functioning will help to inform research that has begun to establish the potential for use of these neuropeptides in psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits. For this study, we will recruit 150 healthy adults without a history of medical or psychiatric illness to come to the laboratory. In the first session, participants will complete several questionnaires. In the second session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo. The study nurses will measure temperature, heart rate, and blood pressure (female participants will also be asked to undergo a pregnancy test) before drug administration. Participants will then complete computer tasks. During the second session, we will also collect a saliva sample for genetic analysis and participants will be asked to complete several additional questionnaires. At the end of the experimental session, participants will be fully debriefed.\n\nThe investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will improve social working memory and deception detection, and increase empathy and altruism. It is also hypothesized that main effects will not be found for oxytocin or vasopressin, but rather, analyses of relevant moderators will elucidate these findings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-50 years of age\n* Healthy (see below)\n* Fluent in English\n\nExclusion Criteria:\n\n* Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women\n* Symptoms of runny nose due to allergies/cold or other reason\n* Current restricted fluid intake for any reason\n* Heart disease\n* Hypertension\n* History of myocardial infarction\n* History of cardiac arrhythmia\n* Kidney or liver disease\n* Vascular disease\n* Epilepsy\n* Migraine\n* Asthma\n* Nephritis\n* Diabetes and other endocrine diseases\n* Frequent or unexplained fainting\n* History of stroke\n* Aneurysm or brain hemorrhage\n* Active psychiatric diagnosis\n* Current psychopharmacologic treatment\n* Drug or alcohol abuse\n* Medical or neurological illness\n* Regular use of medication (e.g., vasoconstrictive medications)\n* Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs\n* Smoking more than 15 cigarettes a day\n* Consumption of any alcoholic beverages in the past 24 hours will be excluded\n* Elevated blood pressure (\\>130/90)\n* Low blood pressure (\\<90/60)\n* Body temperature \\>100.1 F'}, 'identificationModule': {'nctId': 'NCT01680718', 'briefTitle': 'Neuropeptides and Social Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Neuropeptides and Social Behavior', 'orgStudyIdInfo': {'id': 'Behavioral Neuropeptides'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal oxytocin', 'description': 'Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).', 'interventionNames': ['Drug: Intranasal oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal vasopressin', 'description': 'Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).', 'interventionNames': ['Drug: Intranasal vasopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intranasal placebo', 'description': '2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010). Participants will self-administer 5 puffs per nostril.', 'interventionNames': ['Drug: Intranasal placebo']}], 'interventions': [{'name': 'Intranasal oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon nasal spray'], 'description': 'Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).', 'armGroupLabels': ['Intranasal oxytocin']}, {'name': 'Intranasal vasopressin', 'type': 'DRUG', 'description': 'Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).', 'armGroupLabels': ['Intranasal vasopressin']}, {'name': 'Intranasal placebo', 'type': 'DRUG', 'description': 'Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010).', 'armGroupLabels': ['Intranasal placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1563', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Psychology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Naomi I Eisenberger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Naomi Eisenberger', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}