Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 2:07 AM
Study NCT ID:
NCT02393456
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin and the Social Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-03-15', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task versus the inclusion portion. A first-level analysis will compare \\[(friend exclusion\\>friend inclusion)\\>(stranger exclusion\\>stranger inclusion)\\] for each participant. A second-level group analysis will compare these first-level contrasts between the oxytocin and placebo groups.'}], 'secondaryOutcomes': [{'measure': 'Ratings of empathic concern after witnessing social exclusion in a friend or a stranger', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'Ratings of empathic concern will be calculated for each participant by deriving a composite from self-report ratings of sympathy and compassion. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) as well as the interaction between drug condition and target (friend, stranger) will be analyzed at a significance level of p\\<.05.'}, {'measure': 'Altruism and punishment as measured by number of points given to excluders and those excluded', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'Ratings of altruism and punishment will be calculated by examining how many point (1-10) participants decide to allocate towards the friend-excluder, stranger-excluder, excluded friend, and excluded stranger after watching each social exclusion game. Using a mixed 2 (friend, stranger) x 2 (oxytocin, placebo) factorial design, comparisons of these ratings will then be made for those in the oxytocin vs. placebo groups. Main effects of drug condition (oxytocin, placebo) and target (friend, stranger), as well as an interaction between drug condition and target will be analyzed at a significance level of p\\<.05.'}, {'measure': 'Changes in neural brain activity, as observed by fMRI, while attempting to detect deception', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the deception detection task versus a control task. A first-level analysis will compare deception-detection\\>control for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.'}, {'measure': 'Accuracy of deception detection as measured by self-report', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'We will compare the percentage of correct deception detection trials for participants in the oxytocin group to those in the placebo group by running a two-tailed t-test with a statistical cutoff of p\\<.05 to determine significance.'}, {'measure': 'Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers', 'timeFrame': 'Between 40-115 minutes post administration', 'description': 'Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the oxytocin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater while viewing photo stimuli of ones primary caregivers versus viewing photo stimuli of matched strangers. A first-level analysis will compare primary-caregiver-viewing\\>stranger-viewing for each participant. A second-level group analysis will compare this first-level contrast between the oxytocin and placebo groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Social Psychology']}, 'referencesModule': {'references': [{'pmid': '37310308', 'type': 'DERIVED', 'citation': 'Straccia MA, Teed AR, Katzman PL, Tan KM, Parrish MH, Irwin MR, Eisenberger NI, Lieberman MD, Tabak BA. Null results of oxytocin and vasopressin administration on mentalizing in a large fMRI sample: evidence from a randomized controlled trial. Psychol Med. 2023 Apr;53(6):2285-2295. doi: 10.1017/S0033291721004104. Epub 2021 Oct 15.'}]}, 'descriptionModule': {'briefSummary': "It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators 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, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide 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's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin on several tasks involving social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning will help to inform research that has begun to establish the potential for use of this neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits.\n\nThe investigators hypothesize that compared to placebo, oxytocin will improve deception detection, increase empathy and altruism, and enhance responses to photo stimuli of primary caregivers. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for oxytocin, but rather, analyses of relevant moderators will elucidate these findings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 years of age\n* Healthy (see below)\n* Fluent in English\n* Right-handed\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 (\\>135/90)\n* Low blood pressure (\\<90/55)\n* Body temperature \\>100.1 F\n* Left-handed\n* Claustrophobia\n* Presence of metal in their body'}, 'identificationModule': {'nctId': 'NCT02393456', 'briefTitle': 'Oxytocin and the Social Brain', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': "Oxytocin's Effects on Behavior and Neural Activity During Social Cognition Tasks", 'orgStudyIdInfo': {'id': '11-003565-2'}}, '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': '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. 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 placebo', 'type': 'DRUG', 'otherNames': ['Glycerine solution'], '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.', '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': 'Matthew D Lieberman, 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': 'Matthew D. Lieberman, PhD', 'investigatorFullName': 'Matthew Lieberman', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}