Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT03846505
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2019-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sellersst@musc.edu', 'phone': '8437925807', 'title': 'Stacey Sellers, Lab Manager', 'organization': 'Medical University of South Carolina - Institute of Psychiatry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nOxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 49, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nPlacebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 38, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Coronavirus infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache/Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injury/Accident', 'notes': 'skin burn; burned hand; broken hand; hand wound; finger laceration; facial abrasion; facial contusion; facial scrape; scratched cornea; back injury; torn rotator cuff; broken foot; foot injury; fall resulting in knee/foot abrasions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Stroke', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Appendectomy', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hernia surgery', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide attempt', 'notes': '(pills) with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Supraventricular tachycardia/arrhythmia', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inpatient alcohol detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thoracic injury', 'notes': 'with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nOxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nPlacebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '48.1'}, {'value': '35.9', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '47.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 12', 'description': 'Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes.\n\nTime Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month).', 'unitOfMeasure': 'percentage of days abstinent for alcohol', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nOxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nPlacebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '26.2'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '26.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 12', 'description': 'Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nOxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nPlacebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '21.2'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '19.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 12', 'description': 'Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (\\> 4 standard drinks for women or \\> 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes.', 'unitOfMeasure': 'percentage of heavy drinking days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change in Alcohol Problem Severity - Measured by Alcohol Use Disorder Identification Test (AUDIT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nOxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.\n\nPlacebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '16.4'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '14.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 12', 'description': 'Change in alcohol problem severity was measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. The AUDIT was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0 to 40, with scores of 15 or greater representing moderate to severe Alcohol Use Disorder (AUD).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': "Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partner Has Alcohol Use Disorder (AUD)', 'description': 'Partners of patients were categorized as having Alcohol Use Disorder (AUD) if they scored 15 or greater on the Alcohol Use Disorder Identification Test (AUDIT)'}, {'id': 'OG001', 'title': 'Partner Does Not Have Alcohol Use Disorder (AUD)', 'description': 'Partners of patients were categorized as not having Alcohol Use Disorder (AUD) if they scored below 15 on the Alcohol Use Disorder Identification Test (AUDIT)'}], 'classes': [{'title': 'Percent days abstinent', 'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Percent heavy drinking days', 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000'}, {'value': '-0.39', 'groupId': 'OG001'}]}]}, {'title': 'Relationship functioning', 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000'}, {'value': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Alcohol problem severity', 'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000'}, {'value': '-0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 12', 'description': "Between-group differences in patients' outcomes based on partners' alcohol use disorder (AUD) status measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. Scores range from 0-40 on the AUDIT, with higher scores representing greater problems with alcohol use, and 15 or greater representing AUD.\n\nGroup differences in patient outcomes included percent days abstinent and percent days heaving drinking, measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview. Outcomes also included patients' relationship functioning, measured by the Dyadic Adjustment Scale-Short Form (DAS-7), a 7-item Likert-type self-report measure, and patients' alcohol problem severity, measured by the AUDIT, a 10-item Likert-type self-report measure.\n\nDAS score ranges from 0 to 36, with a higher score indicating more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress.", 'unitOfMeasure': "Cohen's D", 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin', 'description': 'A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session.\n\nAll participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session.\n\nAll participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.'}], 'periods': [{'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Opted out of intervention but completed assessments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Completed Follow Up Phase (6-month)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited through internet advertisements, clinician referrals, and flyers. Following preliminary eligibility screening, Identified Patients and partners completed private written informed and a baseline assessment separately for privacy. The baseline assessment included a history and physical (H\\&P) exam and a battery of standardized self-report and interview measures.\n\nRecruitment and enrollment occurred from May 2019 to April 2023.', 'preAssignmentDetails': 'Participants were 96 adult romantic couples (total N=192) where at least one partner met diagnostic criteria for Alcohol Use Disorder in the past 6 months.Couples were required to have been in their current relationship for at least 6 months. Participants who were taking psychotropic medications were required to be on a stable dose for 4 weeks before enrolling.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin', 'description': 'A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session.\n\nAll participants assigned to12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session.\n\nAll participants assigned to 12 weekly, 90-minute therapy therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Identified Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '12.2', 'groupId': 'BG002'}]}]}, {'title': 'Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '12', 'groupId': 'BG001'}, {'value': '40.35', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Identified Patient and Partner listed in individual rows.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Identified Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Identified Patient and Partner listed in individual rows.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '181', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Identified Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': 'Identified Patient and Partner listed in individual rows.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 610338, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-16T15:12', 'hasProtocol': True}, {'date': '2022-08-16', 'size': 328569, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-16T15:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Oxytocin and Therapy Placebo and Therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2019-02-17', 'resultsFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2019-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-27', 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes.\n\nTime Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month).'}, {'measure': 'Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning.'}, {'measure': 'Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (\\> 4 standard drinks for women or \\> 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Couple', 'Alcohol', 'Therapy'], 'conditions': ['Alcohol Use Disorder', 'Couples']}, 'descriptionModule': {'briefSummary': 'Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intranasal oxytocin is a medication that holds promise to achieve that goal. Oxytocin has demonstrated the ability to increase prosocial behavior (e.g., trust, safety, social cognition) and restore sensitivity to natural rewards such as interpersonal relationships that are commonly eroded in the context of addiction. Oxytocin has also demonstrated the ability to reduce substance use behaviors (e.g., craving, self-administration, tolerance, withdrawal), and improves the neurobiological foundations of AUD. The primary objective of this Stage II study is to test the efficacy of oxytocin versus placebo in improving (1) AUD symptom severity, (2) relationship functioning, and (3) corticolimbic connectivity among couples receiving ABCT therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Male or female; any race or ethnicity; aged 18-75 years.\n2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (\\> 26 on the Mini-Mental State Exam).\n3. Married, cohabiting, or in a committed relationship for ≥ 6 months.\n4. Identified Patients (IPs) must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for current alcohol use disorder. Couples in which both partners meet diagnostic criteria for current Alcohol Use Disorder (AUD) are eligible for participation.\n5. Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.\n6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.\n\nExclusion criteria\n\n1. Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those individuals will be referred clinically for treatment.\n2. Participants who present a serious suicide risk or are likely to require hospitalization during the study.\n3. Participants on psychotropic medications which have been initiated during the past 4 weeks. They may be re-assessed after at least four weeks on a stable dose.\n4. Acute alcohol withdrawal as indicated by Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores \\>8. They may be re-assessed once they are no longer in withdrawal. Those individuals will be referred for medically supervised detoxification.\n5. Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).\n6. Pregnancy or breastfeeding for women.\n7. Individuals with implanted metal devices above the waist will be eligible to enroll in the clinical trial but will not be eligible to participate in the neuroimaging component of the study."}, 'identificationModule': {'nctId': 'NCT03846505', 'briefTitle': 'Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)', 'orgStudyIdInfo': {'id': 'Pro00082233'}, 'secondaryIdInfos': [{'id': '1R01AA027212', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA027212', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.\n\nAll participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Pitocin'], 'description': 'A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.', 'armGroupLabels': ['Oxytocin']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Saline'], 'description': 'A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Julianne Flanagan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Psychiatry and Behavioral Sciences, Addiction Sciences', 'investigatorFullName': 'Julianne Flanagan', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}