Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-06 @ 9:23 PM
Study NCT ID:
NCT03047005
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2017-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621664', 'term': 'Naltrexone-Bupropion combination'}, {'id': 'C000591595', 'term': 'bupropion hydrochloride, naltrexone hydrochoride drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carlos.grilo@yale.edu', 'phone': '203 785 7210', 'title': 'Dr. Carlos Grilo', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Month 1', 'description': 'Participants were interviewed by research clinicians. For non-serious adverse events that were listed as \\>5% on the package insert for "Contrave" (naltrexone HCl/ bupropion HCl), we provide the total participants \\[all available data\\] who reported the adverse event at month 1. For serious adverse events, we provide the total participants \\[all available data\\] who reported the adverse event over the course of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 21, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 18, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binge Eating Frequency (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '7.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.07', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.', 'nonInferiorityComment': 'Analyses used all available data. Analyses to compare treatments were all intent-to-treat.'}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (4 months)', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).', 'unitOfMeasure': 'binge eating days per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '.05', 'groupId': 'OG000'}, {'value': '.01', 'spread': '.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.', 'nonInferiorityComment': 'Analyses used all available data. Analyses to compare treatments were all intent-to-treat.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and Post-treatment (4 months)', 'description': 'BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.', 'unitOfMeasure': 'percentage weight change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binge Eating Frequency (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '4.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-Month Follow-up', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).', 'unitOfMeasure': 'eating events/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binge Eating Frequency (Continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '6.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-Month Follow-up', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).', 'unitOfMeasure': 'eating events/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '.004', 'spread': '.065', 'groupId': 'OG000'}, {'value': '.026', 'spread': '.063', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6-Month Follow-up', 'description': 'BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.', 'unitOfMeasure': 'percentage change in BMI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '.025', 'spread': '.079', 'groupId': 'OG000'}, {'value': '.042', 'spread': '.076', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12-Month Follow-up', 'description': 'BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.', 'unitOfMeasure': 'percentage change in BMI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'The main study (acute treatment results) can be found in NCT03045341. Two participants dropped prior to beginning the medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NB Medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.\n\nNB medication (Naltrexone Bupropion combination): NB medication'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.40', 'spread': '11.70', 'groupId': 'BG000'}, {'value': '43.60', 'spread': '11.80', 'groupId': 'BG001'}, {'value': '46.92', 'spread': '12.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Men', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Women', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', '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': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', '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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 818375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-22T14:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2017-02-05', 'resultsFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2017-02-05', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-14', 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge Eating Frequency (Continuous)', 'timeFrame': 'Post-treatment (4 months)', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'baseline and Post-treatment (4 months)', 'description': 'BMI is calculated using measured height and weight. We report percent change in weight from baseline. Negative values indicate weight loss.'}], 'secondaryOutcomes': [{'measure': 'Binge Eating Frequency (Continuous)', 'timeFrame': '6-Month Follow-up', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).'}, {'measure': 'Binge Eating Frequency (Continuous)', 'timeFrame': '12-Month Follow-up', 'description': 'Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Baseline to 6-Month Follow-up', 'description': 'BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'Baseline to 12-Month Follow-up', 'description': 'BMI is calculated using measured height and weight. We report percent change in BMI from baseline. Negative values indicate weight loss.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge-Eating Disorder', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.', 'detailedDescription': 'Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participated in acute treatment for binge-eating disorder and obesity;\n* Had a positive response to acute treatment;\n* Available for the duration of the treatment and follow-up (20 months);\n* Read, comprehend, and write English at a sufficient level to complete study-related materials; and\n* Able to travel to study location (New Haven, CT) for monthly visits.\n\nExclusion Criteria:\n\n* Currently taking anti-depressant medications;\n* Currently taking opioid pain medications or drugs;\n* Currently taking medications that influence eating/weight;\n* History of seizures;\n* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);\n* Past or current anorexia nervosa, bulimia nervosa;\n* Pregnant or breastfeeding;\n* Medical status judged by study physician as contraindication.'}, 'identificationModule': {'nctId': 'NCT03047005', 'briefTitle': 'Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Behavioral and Pharmacologic Treatment of Binge Eating and Obesity', 'orgStudyIdInfo': {'id': '1506016065-M'}, 'secondaryIdInfos': [{'id': 'R01DK049587', 'link': 'https://reporter.nih.gov/quickSearch/R01DK049587', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NB medication', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.', 'interventionNames': ['Drug: NB medication (Naltrexone Bupropion combination)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'NB medication (Naltrexone Bupropion combination)', 'type': 'DRUG', 'otherNames': ['Contrave'], 'description': 'NB medication', 'armGroupLabels': ['NB medication']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Carlos M Grilo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}