{"protocolSection":{"identificationModule":{"nctId":"NCT03539900","orgStudyIdInfo":{"id":"2000021769"},"secondaryIdInfos":[{"id":"R01DK112771","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DK112771"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder","officialTitle":"Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder"},"statusModule":{"statusVerifiedDate":"2024-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-04-17","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-04-19","type":"ACTUAL"},"completionDateStruct":{"date":"2023-03-22","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-16","studyFirstSubmitQcDate":"2018-05-16","studyFirstPostDateStruct":{"date":"2018-05-29","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-04-17","resultsFirstSubmitQcDate":"2023-06-30","resultsFirstPostDateStruct":{"date":"2023-07-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-03-11","lastUpdatePostDateStruct":{"date":"2024-04-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"},"collaborators":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.","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 BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB."},"conditionsModule":{"conditions":["Binge-Eating Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":89,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"NB Medication","type":"EXPERIMENTAL","description":"Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination","interventionNames":["Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo will be inactive and taken daily in pill form.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination","description":"NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.","armGroupLabels":["NB Medication"],"otherNames":["Contrave"]},{"type":"OTHER","name":"Placebo","description":"Placebo will be inactive and taken daily in pill form.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment.\"","timeFrame":"Post-treatment (3 months)"},{"measure":"Percent BMI Change","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at posttreatment\\] - \\[BMI at baseline\\])/\\[BMI at baseline\\]. Negative values indicate loss.","timeFrame":"Post-treatment (3 months)"}],"secondaryOutcomes":[{"measure":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.","timeFrame":"6 months post-treatment"},{"measure":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.","timeFrame":"12 months post-treatment"},{"measure":"Body Mass Index","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at 6 month followup\\] - \\[BMI at posttreatment\\])/\\[BMI at posttreatment\\]. Negative values indicate loss.","timeFrame":"6 months post-treatment"},{"measure":"Body Mass Index","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at 12 month followup\\] - \\[BMI at posttreatment\\])/\\[BMI at posttreatment\\]. Negative values indicate loss.","timeFrame":"12 months post-treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);\n* BMI in the obesity (BMI \\>30 and \\<50) or non-obesity (BMI \\>21.5 and \\<29.9) range;\n* Available for the duration of the treatment and follow-up (15 months);\n* Read, comprehend, and write English at a sufficient level to complete study-related materials.\n\nExclusion Criteria:\n\n* Currently taking opioid pain medications or drugs; or positive drug screen for opiates\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 or bulimia nervosa;\n* Pregnant or breastfeeding;\n* Medical status judged by study physician as contraindication.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carlos M Grilo, PhD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Sherry McKee, PhD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","zip":"06520","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"FG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"46"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"44"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"BG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"89"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.3","spread":"14.0"},{"groupId":"BG001","value":"46.0","spread":"13.2"},{"groupId":"BG002","value":"45.7","spread":"13.5"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Men","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"24"}]}]},{"title":"Women","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"63"}]}]},{"title":"Another gender","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"83"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"17"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"62"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"89"}]}]}]},{"title":"Sexual Orientation","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Heterosexual","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"80"}]},{"title":"Homosexual","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Bisexual","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]},{"title":"Education","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"High School","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"16"}]},{"title":"Some College","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"34"}]},{"title":"College","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"16"}]},{"title":"More than College","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"23"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment.\"","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"binge-eating episodes per month","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.4","spread":"10.6"},{"groupId":"OG001","value":"5.4","spread":"9.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data. Analyses to compare treatments were all intent-to-treat.","pValue":".44","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor."}]},{"type":"PRIMARY","title":"Percent BMI Change","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at posttreatment\\] - \\[BMI at baseline\\])/\\[BMI at baseline\\]. Negative values indicate loss.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent BMI change","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.0","spread":"11.3"},{"groupId":"OG001","value":"-0.5","spread":"8.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data. Analyses to compare treatments were all intent-to-treat.","pValue":".04","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator."}]},{"type":"SECONDARY","title":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"binge-eating episodes per month","timeFrame":"6 months post-treatment","groups":[{"id":"OG000","title":"NB Medication","description":"Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"23"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.67","spread":"6.29"},{"groupId":"OG001","value":"6.00","spread":"9.54"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".98","statisticalMethod":"ANOVA","statisticalComment":"Analyses used all available data without imputation."}]},{"type":"SECONDARY","title":"Change in Binge Eating Frequency","description":"Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"binge-eating episodes per month","timeFrame":"12 months post-treatment","groups":[{"id":"OG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.36","spread":"14.87"},{"groupId":"OG001","value":"5.33","spread":"6.82"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".44","statisticalMethod":"ANOVA","statisticalComment":"Analyses used all available data without imputation."}]},{"type":"SECONDARY","title":"Body Mass Index","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at 6 month followup\\] - \\[BMI at posttreatment\\])/\\[BMI at posttreatment\\]. Negative values indicate loss.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent BMI change","timeFrame":"6 months post-treatment","groups":[{"id":"OG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.04","spread":"10.51"},{"groupId":"OG001","value":"0.05","spread":"4.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".99","statisticalMethod":"ANOVA","statisticalComment":"Analyses used all available data without imputation."}]},{"type":"SECONDARY","title":"Body Mass Index","description":"BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\\[BMI at 12 month followup\\] - \\[BMI at posttreatment\\])/\\[BMI at posttreatment\\]. Negative values indicate loss.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent BMI change","timeFrame":"12 months post-treatment","groups":[{"id":"OG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form."},{"id":"OG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"12.18"},{"groupId":"OG001","value":"3.43","spread":"7.86"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".40","statisticalMethod":"ANOVA","statisticalComment":"Analyses used all available data without imputation."}]}]},"adverseEventsModule":{"frequencyThreshold":"5","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.","eventGroups":[{"id":"EG000","title":"NB Medication","description":"Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)\n\nBupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination: NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.","deathsNumAffected":0,"deathsNumAtRisk":43,"seriousNumAffected":0,"seriousNumAtRisk":43,"otherNumAffected":26,"otherNumAtRisk":43},{"id":"EG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form.\n\nPlacebo: Placebo will be inactive and taken daily in pill form.","deathsNumAffected":0,"deathsNumAtRisk":46,"seriousNumAffected":0,"seriousNumAtRisk":46,"otherNumAffected":26,"otherNumAtRisk":46}],"otherEvents":[{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":43},{"groupId":"EG001","numAffected":0,"numAtRisk":46}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":43},{"groupId":"EG001","numAffected":3,"numAtRisk":46}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":43},{"groupId":"EG001","numAffected":5,"numAtRisk":46}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":43},{"groupId":"EG001","numAffected":4,"numAtRisk":46}]},{"term":"Dry Mouth","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":43},{"groupId":"EG001","numAffected":4,"numAtRisk":46}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":43},{"groupId":"EG001","numAffected":9,"numAtRisk":46}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":43},{"groupId":"EG001","numAffected":6,"numAtRisk":46}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":43},{"groupId":"EG001","numAffected":4,"numAtRisk":46}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":43},{"groupId":"EG001","numAffected":4,"numAtRisk":46}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr Carlos Grilo","organization":"Yale University","email":"carlos.grilo@yale.edu","phone":"203 785 7210"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2022-04-04","uploadDate":"2023-04-14T14:12","filename":"Prot_SAP_000.pdf","size":522116},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2021-05-26","uploadDate":"2023-04-14T14:13","filename":"ICF_001.pdf","size":241145}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2023-05-10","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D056912","term":"Binge-Eating Disorder"}],"ancestors":[{"id":"D001068","term":"Feeding and Eating Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591595","term":"bupropion hydrochloride, naltrexone hydrochoride drug combination"}]}},"hasResults":true}