Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 9:15 PM
Study NCT ID:
NCT07093060
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Oxytocin and Atosiban on Social Attention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'C047046', 'term': 'atosiban'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled double-blind between-subject design experiment including 5 treatment groups receiving oral oxytocin, atosiban, or placebo interventions prior to performing visual attention tasks'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fixation duration', 'timeFrame': 'Fixation durations will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes)', 'description': 'Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking'}, {'measure': 'Fixation counts', 'timeFrame': 'Fixation counts will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment, from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes).', 'description': 'Total number of fixations made by participant towards the different areas of interest in the different visual paradigms using eye-tracking'}], 'secondaryOutcomes': [{'measure': 'Oxytocin concentration', 'timeFrame': 'Blood samples taken at time 0 (baseline), 15 minutes after first treatment, and 30 minutes after second treatment. Saliva samples taken at time 0 (baseline) and after visual paradigms (around 90 minutes post treatment).', 'description': 'OT concentrations will be measured in blood (plasma) samples (6ml) taken from indwelling catheter in median cubital vein and saliva samples (1-2 ml) taken using passive drool. Oxytocin concentrations will be measured using appropriate assays.'}, {'measure': 'Pupil size', 'timeFrame': 'Pupil size will be measured starting 45 min post-treatment during the whole of each of the different visual presentation paradigms (around 10 minutes for each paradigm).', 'description': 'Pupil size will be measured while subjects view different areas of interest in different visual presentation paradigms using an eye-tracker'}, {'measure': 'State anxiety', 'timeFrame': 'Subjects will complete the questionnaire twice, once immediately prior to treatment (baseline) and a second time immediately after completion of the four visual paradigms (around 90 minutes post treatment).', 'description': 'State anxiety will be measured using a questionnaire (40 self-report question - State-Trait Anxiety Inventory, with total scores ranging from 20 to 80, where higher scores indicate greater anxiety).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxytocin', 'Atosiban', 'Eye tracking', 'Autistic trait'], 'conditions': ['Healhty']}, 'descriptionModule': {'briefSummary': 'The main aim of the present study is to investigate whether orally (lingual spray) administered oxytocin influences human social attention and behaviors via oxytocin receptors and whether its effects are dose- and task-dependent.', 'detailedDescription': "In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate whether oral (lingual spray) oxytocin influences human social attention and behaviors via the oxytocin receptor and whether its effects are dose- and task-dependent. Participants complete questionnaires in Chinese versions before treatment administration, including Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6 ml via indwelling medial cubital vein catheter) and saliva (1-2 ml, passive drool) samples are collected, followed by the first self-administered medication (three sublingual and three supragingival administrations, alternating separated by 30 seconds). After a 15-minute interval, the second medication is administered, with a second blood sample collected immediately afterwards. Participants then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters prohibited during this period). Behavioral experiments commence after the third blood collection. Behavioral experiment consists of four visual attention paradigms including a dynamic task simultaneously contrasting social stimuli (individuals dancing) with geometric patterns; social directed attention using a gaze following paradigm; face emotion processing, and empathy for individuals depicted in natural scenes exhibiting strong positive or negative emotions. During these phases, participants' fixation time, fixation counts and pupil size on specified areas of interest during each visual attention paradigm will be measured using eye tracking equipment. Immediately after completion of the paradigm, participants will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.\n\nMANOVA tests followed by appropriate post-hoc analyses will be performed on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between trait autism scores and outcome measures in the different groups.\n\nInvestigators hypothesize that oral oxytocin treatment will dose-dependently facilitate enhanced interest in social stimuli or features in the different visual attention paradigms and dose-dependently increase oxytocin concentrations. Investigators additionally hypothesize that the oxytocin receptor antagonist, atosiban, will reduce interest in social stimuli or features and will prevent facilitatory effects of oxytocin administration but not influence oxytocin concentrations. Investigators hypothesize that oxytocin treatment will increase pupil diameter while viewing some of the social stimuli. Investigators hypothesize that there will be no treatment-dependent effects on state anxiety. Investigators hypothesize that oxytocin effects on enhancing social attention will be greater in individuals with higher scores on trait autism."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy male subjects without past or current psychiatric or neurological disorders', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects without past or current psychiatric or neurological disorders\n\nExclusion Criteria:\n\n* History of or current neurological/psychiatric disorders;\n* Use of psychotropic medications (including nicotine)\n* Visual impairments'}, 'identificationModule': {'nctId': 'NCT07093060', 'acronym': 'OTAtosiban', 'briefTitle': 'The Effect of Oral Oxytocin and Atosiban on Social Attention', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Social Attention in Humans', 'orgStudyIdInfo': {'id': '106142023111727716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxytocin 24IU group', 'description': 'Interventions are placebo followed after 15 min by the lower dose (24IU) oxytocin', 'interventionNames': ['Drug: Oxytocin lower dose (24IU)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'atosiban group', 'description': 'Interventions are placebo followed after 15 minutes by 150ug atosiban', 'interventionNames': ['Drug: Atosiban', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Interventions are placebo followed after 15 minutes by another placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'oxytocin 48IU group', 'description': 'Interventions are placebo followed after 15 minutes by the higher 48IU oxytocin dose', 'interventionNames': ['Drug: Oxytocin higher dose (48IU)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Atosiban and 24IU oxytocin group', 'description': 'Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) dose of oxytocin', 'interventionNames': ['Drug: Oxytocin lower dose (24IU)', 'Drug: Atosiban']}], 'interventions': [{'name': 'Oxytocin lower dose (24IU)', 'type': 'DRUG', 'otherNames': ['oral oxytocin 24IU'], 'description': 'Oxytocin (24IU) will be administered as a lingual spray (6, 0.1 puffs (4IU per puff) of spray on and under the tongue)', 'armGroupLabels': ['Atosiban and 24IU oxytocin group', 'oxytocin 24IU group']}, {'name': 'Oxytocin higher dose (48IU)', 'type': 'DRUG', 'otherNames': ['oral oxytocin 48IU'], 'description': '48IU oxytocin administered as a lingual spray (6, 0.1ml sprays (8IU per puff) on or under the tongue)', 'armGroupLabels': ['oxytocin 48IU group']}, {'name': 'Atosiban', 'type': 'DRUG', 'otherNames': ['oral atosiban'], 'description': '150ug atosiban administered by lingual sprays (6, 0.1ml sprays on and under the tongue)', 'armGroupLabels': ['Atosiban and 24IU oxytocin group', 'atosiban group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered as a lingual spray (6, 0.1 ml sprays one and under the tongue. Placebo has the same composition of 0.9% saline and glycerol as for oxytocin and atosiban interventions', 'armGroupLabels': ['atosiban group', 'oxytocin 24IU group', 'oxytocin 48IU group', 'placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhang, MSc', 'role': 'CONTACT', 'email': '532769737@qq.com', 'phone': '+86 18215678419'}], 'facility': 'School of Life science and Technology, University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Keith M Kendrick, PhD', 'role': 'CONTACT', 'email': 'k.kendrick.uestc@gmail.com', 'phone': '86-28-61830811'}, {'name': 'Yige Wang, PhD', 'role': 'CONTACT', 'phone': '86+13086688860'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant data will be shared with other qualified researchers upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Electronic Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keith Kendrick', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}