{"protocolSection":{"identificationModule":{"nctId":"NCT02317744","orgStudyIdInfo":{"id":"1409014705"},"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo","officialTitle":"Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo"},"statusModule":{"statusVerifiedDate":"2017-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-12"},"primaryCompletionDateStruct":{"date":"2016-09","type":"ACTUAL"},"completionDateStruct":{"date":"2016-09","type":"ACTUAL"},"studyFirstSubmitDate":"2014-12-11","studyFirstSubmitQcDate":"2014-12-11","studyFirstPostDateStruct":{"date":"2014-12-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-10-13","resultsFirstSubmitQcDate":"2017-11-21","resultsFirstPostDateStruct":{"date":"2017-12-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-11-21","lastUpdatePostDateStruct":{"date":"2017-12-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"}},"descriptionModule":{"briefSummary":"This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder."},"conditionsModule":{"conditions":["Binge Eating Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Naltrexone/ Bupropion combination","type":"EXPERIMENTAL","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months","interventionNames":["Drug: Naltrexone and bupropion combination"]},{"label":"Pill placebo","type":"PLACEBO_COMPARATOR","description":"Daily placebo medication for 3 months","interventionNames":["Other: Pill Placebo"]}],"interventions":[{"type":"DRUG","name":"Naltrexone and bupropion combination","armGroupLabels":["Naltrexone/ Bupropion combination"]},{"type":"OTHER","name":"Pill Placebo","armGroupLabels":["Pill placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Binge Eating Frequency (Continuous)","description":"Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).","timeFrame":"Post-treatment (at 3 months)"},{"measure":"Binge Eating Frequency (Continuous)","description":"Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).","timeFrame":"6 month follow-up (an average of 6 months following treatment)"}],"secondaryOutcomes":[{"measure":"Body Mass Index (BMI)","description":"BMI is calculated using measured height and weight.","timeFrame":"Post-treatment (at 3 months)"},{"measure":"Body Mass Index (BMI)","description":"BMI is calculated using measured height and weight.","timeFrame":"6 month follow-up (an average of 6 months following 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 between 30 kg/m2 and 50 kg/m2\n* Not taking anti-depressant medications\n* Read English proficiently enough to read study assessments\n* Available for duration of treatment plus follow-up period\n* Able to travel to study location (New Haven, CT) for monthly visits\n* Agree to study procedures\n\nExclusion Criteria:\n\n* Medical status judged by study physician as contraindication\n* History of seizures\n* Past or current anorexia nervosa, bulimia nervosa\n* Current medications that influence eating/weight\n* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment\n* Pregnant or breastfeeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carlos M Grilo, Ph.D.","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}}]},"referencesModule":{"references":[{"pmid":"33218742","type":"DERIVED","citation":"Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"FG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Completed Treatment","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"One NB participant stopped the treatment but completed assessments.","numSubjects":"11"},{"groupId":"FG001","comment":"One Placebo participant stopped the treatment but completed assessments.","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"BG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51.2","spread":"8.0"},{"groupId":"BG001","value":"49.4","spread":"10.1"},{"groupId":"BG002","value":"50.4","spread":"8.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Binge Eating Frequency","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"binge eating days (out of 28)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16.0","lowerLimit":"4","upperLimit":"28"},{"groupId":"BG001","value":"9.2","lowerLimit":"3","upperLimit":"27"},{"groupId":"BG002","value":"12.9","lowerLimit":"3","upperLimit":"27"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.0","lowerLimit":"30","upperLimit":"49"},{"groupId":"BG001","value":"40.1","lowerLimit":"33","upperLimit":"48"},{"groupId":"BG002","value":"37.3","lowerLimit":"30","upperLimit":"49"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Binge Eating Frequency (Continuous)","description":"Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"binge eating days (out of 28)","timeFrame":"Post-treatment (at 3 months)","groups":[{"id":"OG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"OG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.4","lowerLimit":"0","upperLimit":"28"},{"groupId":"OG001","value":"3.0","lowerLimit":"0","upperLimit":"16"}]}]}]},{"type":"PRIMARY","title":"Binge Eating Frequency (Continuous)","description":"Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"binge eating days (out of 28)","timeFrame":"6 month follow-up (an average of 6 months following treatment)","groups":[{"id":"OG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"OG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.4","lowerLimit":"0","upperLimit":"25"},{"groupId":"OG001","value":"2.9","lowerLimit":"0","upperLimit":"14"}]}]}]},{"type":"SECONDARY","title":"Body Mass Index (BMI)","description":"BMI is calculated using measured height and weight.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"kg/m^2","timeFrame":"Post-treatment (at 3 months)","groups":[{"id":"OG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"OG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"9"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.5","lowerLimit":"29","upperLimit":"48"},{"groupId":"OG001","value":"39.7","lowerLimit":"32","upperLimit":"47"}]}]}]},{"type":"SECONDARY","title":"Body Mass Index (BMI)","description":"BMI is calculated using measured height and weight.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Full Range","unitOfMeasure":"kg/m^2","timeFrame":"6 month follow-up (an average of 6 months following treatment)","groups":[{"id":"OG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination"},{"id":"OG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35.9","lowerLimit":"28","upperLimit":"48"},{"groupId":"OG001","value":"40.3","lowerLimit":"34","upperLimit":"45"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"3 months","description":"Participants were interviewed by research clinicians monthly during treatment (3 months) about the absence or presence of side effects.","eventGroups":[{"id":"EG000","title":"Naltrexone/ Bupropion Combination","description":"50 mg naltrexone and 300 mg bupropion per day for 3 months\n\nNaltrexone and bupropion combination","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":11,"otherNumAtRisk":11},{"id":"EG001","title":"Pill Placebo","description":"Daily placebo medication for 3 months\n\nPill Placebo","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":5,"otherNumAtRisk":8}],"otherEvents":[{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 participant discontinued NB because of anxiety; 1 participant discontinued placebo because of anxiety.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":5,"numAtRisk":8}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 participant discontinued NB because of vomiting; 0 participants discontinued placebo because of vomiting.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":8}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":8}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":8}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":4,"numAtRisk":8}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11},{"groupId":"EG001","numAffected":2,"numAtRisk":8}]},{"term":"Hot Flush","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Common Cold","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":8}]},{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Sinusitis","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]},{"term":"Sexual Dysfunction","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":8}]},{"term":"Depression","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":8}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Carlos Grilo","organization":"Yale School of Medicine","email":"carlos.grilo@yale.edu","phone":"203-785-2792"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D056912","term":"Binge-Eating Disorder"}],"ancestors":[{"id":"D001068","term":"Feeding and Eating Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"C000621664","term":"Naltrexone-Bupropion combination"}]}},"hasResults":true}