Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-24 @ 3:18 PM
Study NCT ID:
NCT02941692
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2015-10-01
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oxytocin for Couples Conflict Resolution
Sponsor:
Organization:
Raw JSON
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This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.", 'unitOfMeasure': 'distress maintaining attributions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were limited to heterosexual couples with reliable data reporting in order to accommodate the data analytic approach (i.e., multilevel modeling).'}, {'type': 'SECONDARY', 'title': 'Change in Salivary Cortisol (μg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.\n\nOxytocin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.\n\nPlacebo: Placebo for Oxytocin'}], 'classes': [{'title': 'Time 1 (Baseline)', 'categories': [{'measurements': [{'value': '.28', 'spread': '.18', 'groupId': 'OG000'}, {'value': '.30', 'spread': '.20', 'groupId': 'OG001'}]}]}, {'title': 'Time 2 (Pre Conflict Discussion #1)', 'categories': [{'measurements': [{'value': '.25', 'spread': '.14', 'groupId': 'OG000'}, {'value': '.29', 'spread': '.18', 'groupId': 'OG001'}]}]}, {'title': 'Time 3 (Post Conflict Discussion #1)', 'categories': [{'measurements': [{'value': '.18', 'spread': '.11', 'groupId': 'OG000'}, {'value': '.21', 'spread': '.12', 'groupId': 'OG001'}]}]}, {'title': 'Time 4 (Post Conflit Discussion #2)', 'categories': [{'measurements': [{'value': '.17', 'spread': '.11', 'groupId': 'OG000'}, {'value': '.22', 'spread': '.16', 'groupId': 'OG001'}]}]}, {'title': 'Time 5 (15 minutes Post Conflict Discussion)', 'categories': [{'measurements': [{'value': '.16', 'spread': '.10', 'groupId': 'OG000'}, {'value': '.22', 'spread': '.20', 'groupId': 'OG001'}]}]}, {'title': 'Time 6 (30 minutes Post Conflict Discussion)', 'categories': [{'measurements': [{'value': '.17', 'spread': '.10', 'groupId': 'OG000'}, {'value': '.22', 'spread': '.18', 'groupId': 'OG001'}]}]}, {'title': 'Time 7 (60 Minutes Post Conflict Discussion)', 'categories': [{'measurements': [{'value': '.16', 'spread': '.08', 'groupId': 'OG000'}, {'value': '.19', 'spread': '.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.', 'description': 'Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three couples (6 total participants) were not included in analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin', 'description': 'Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.\n\nOxytocin'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.\n\nPlacebo: Placebo for Oxytocin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin', 'description': 'Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.\n\nOxytocin'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.\n\nPlacebo: Placebo for Oxytocin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.97', 'spread': '10.17', 'groupId': 'BG000'}, {'value': '32.21', 'spread': '9.73', 'groupId': 'BG001'}, {'value': '32.08', 'spread': '9.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-23', 'size': 320673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-26T15:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2015-10-01', 'resultsFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2016-10-20', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-14', 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frequency of Distress Maintaining Attributions', 'timeFrame': 'Frequency of distress maintaining attrbibutions per 10 minutes', 'description': "Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions."}], 'secondaryOutcomes': [{'measure': 'Change in Salivary Cortisol (μg/dL)', 'timeFrame': 'Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.', 'description': 'Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Substance Misuse', 'Interpersonal Conflict', 'Neuroendocrine Reactivity']}, 'descriptionModule': {'briefSummary': "Oxytocin is a promising new medication found to have positive effects on prosocial behavior, reduce negative affect such as fear and anxiety, and reduce stress-induced addictive behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal oxytocin improves couples' conflict resolution skills and subjective, physiological, and neuroendocrine responses to conflict. Conflict resolution discussions will take place in the laboratory and will be videotaped.", 'detailedDescription': "Substance use disorders (SUD) are characterized by dysregulation of the hypothalamic-pituitary axis (HPA). The neuropeptide oxytocin, commonly administered as an intranasal spray, is a drug that has prominent anxiolytic and prosocial effects on human behaviors. While the mechanisms of action facilitating the behavioral effects of oxytocin in humans is complex and many questions about this process remain, there is a consensus in the existing literature that oxytocin modulates HPA axis reactivity to stressful social stimuli. Preliminary studies suggest that oxytocin is known to reduce couple conflict among normative couples. A more developed line of research indicates that oxytocin mitigates addictive behaviors in the context of various drugs of abuse. Given the high prevalence and severity of dyadic conflict among couples where one or both partner has substance abuse, and given the salience of dyadic conflict as a precipitant to substance use behaviors, it is critical to investigate the therapeutic effects of oxytocin among couples with substance use problems. Namely, oxytocin holds promise as a potential augmenter for conjoint couples therapies, particularly those targeting the reduction of substance use problems. However, only two studies have examined the effects of oxytocin on couples' communication behaviors. Those two studies found that couples' communication skills improved following the administration of oxytocin. It is important to extend this line of research to examine conflict resolution skills among couples with substance use problems. To date, no studies have examined the effects of oxytocin on subjective, physiological, or neuroendocrine reactivity to dyadic conflict. The present study aims to fill that gap in the literature."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 years of age\n2. both partners are willing to participate, and\n3. at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for women, 6 or more for men) or illicit drug use during the past 60 days\n\nExclusion Criteria:\n\n1. pregnancy for women\n2. current psychotic or bipolar disorders\n3. active suicidal or homicidal ideation and intent\n4. subjects who would present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study\n5. severe, unilateral intimate partner violence in the past year\n6. BMI greater than 39.'}, 'identificationModule': {'nctId': 'NCT02941692', 'briefTitle': 'Oxytocin for Couples Conflict Resolution', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'The Effects of Oxytocin on Couples Conflict Resolution Interactions', 'orgStudyIdInfo': {'id': '31736'}, 'secondaryIdInfos': [{'id': 'K12HD055885', 'link': 'https://reporter.nih.gov/quickSearch/K12HD055885', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Pitocin'], 'armGroupLabels': ['Oxytocin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for Oxytocin', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}