{"protocolSection":{"identificationModule":{"nctId":"NCT03045341","orgStudyIdInfo":{"id":"1506016065-A"},"secondaryIdInfos":[{"id":"R01DK049587","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DK049587"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment","officialTitle":"Behavioral and Pharmacologic Treatment of Binge Eating and Obesity"},"statusModule":{"statusVerifiedDate":"2023-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-02-27","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-07-23","type":"ACTUAL"},"completionDateStruct":{"date":"2022-12-16","type":"ACTUAL"},"studyFirstSubmitDate":"2017-02-03","studyFirstSubmitQcDate":"2017-02-03","studyFirstPostDateStruct":{"date":"2017-02-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-07-22","resultsFirstSubmitQcDate":"2022-11-23","resultsFirstPostDateStruct":{"date":"2022-12-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-03-03","lastUpdatePostDateStruct":{"date":"2023-03-08","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":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.","detailedDescription":"Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity."},"conditionsModule":{"conditions":["Binge-eating Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":136,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"BWL + NB medication","type":"EXPERIMENTAL","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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)","Behavioral: Behavioral Weight Loss (BWL) counseling"]},{"label":"BWL + Placebo","type":"EXPERIMENTAL","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.","interventionNames":["Behavioral: Behavioral Weight Loss (BWL) counseling","Other: Placebo"]},{"label":"NB medication","type":"EXPERIMENTAL","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)"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","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":[{"type":"DRUG","name":"NB medication (Naltrexone Bupropion combination)","description":"NB medication","armGroupLabels":["BWL + NB medication","NB medication"],"otherNames":["Contrave"]},{"type":"BEHAVIORAL","name":"Behavioral Weight Loss (BWL) counseling","description":"BWL counseling","armGroupLabels":["BWL + NB medication","BWL + Placebo"]},{"type":"OTHER","name":"Placebo","description":"Placebo","armGroupLabels":["BWL + Placebo","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 will be defined continuously (analyzed dimensionally).","timeFrame":"Post-treatment (4 months)"},{"measure":"Body Mass Index (Percent Weight Loss)","description":"BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.","timeFrame":"Post-treatment (4 months)"}],"secondaryOutcomes":[{"measure":"Number of Participants Meeting Response Criteria","description":"Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline.","timeFrame":"Post-treatment (4 months)"}]},"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 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \\<50;\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;\n* Able to travel to study location (New Haven, CT) for weekly 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.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Carlos Grilo, 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}}]},"referencesModule":{"references":[{"pmid":"36285406","type":"DERIVED","citation":"Grilo CM, Lydecker JA, Fineberg SK, Moreno JO, Ivezaj V, Gueorguieva R. Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2022 Dec 1;179(12):927-937. doi: 10.1176/appi.ajp.20220267. Epub 2022 Oct 26."}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","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":"FG001","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":"FG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo"},{"id":"FG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"35"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"27"},{"groupId":"FG003","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","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":"BG001","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":"BG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo"},{"id":"BG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling"},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"35"},{"groupId":"BG003","value":"35"},{"groupId":"BG004","value":"136"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.94","spread":"12.57"},{"groupId":"BG001","value":"46.03","spread":"11.95"},{"groupId":"BG002","value":"46.00","spread":"11.87"},{"groupId":"BG003","value":"46.99","spread":"12.98"},{"groupId":"BG004","value":"46.50","spread":"12.23"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Male","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"22"}]}]},{"title":"Female","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"111"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"20"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"116"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","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"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"18"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"26"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"106"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"7"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Sexual Orientation","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Heterosexual","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"125"}]},{"title":"Gay or Lesbian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]},{"title":"Bisexual","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"4"}]},{"title":"Other","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}]}]}]},{"title":"Education","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"High School","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"21"}]},{"title":"Some College","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"40"}]},{"title":"College","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"32"}]},{"title":"More than College","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"43"}]}]}]}]},"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 will be defined continuously (analyzed dimensionally).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"binge-eating episodes per month","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","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":"OG001","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":"OG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo"},{"id":"OG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"27"},{"groupId":"OG003","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.90","spread":"20.31"},{"groupId":"OG001","value":"7.63","spread":"9.77"},{"groupId":"OG002","value":"3.30","spread":"5.28"},{"groupId":"OG003","value":"1.97","spread":"4.87"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"BWL versus no BWL","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data.","pValue":"0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session."},{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"NB versus placebo","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data.","pValue":"0.58","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session."}]},{"type":"PRIMARY","title":"Body Mass Index (Percent Weight Loss)","description":"BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.","populationDescription":"Analyses used all available data.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of baseline weight","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","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":"OG001","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":"OG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo"},{"id":"OG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.05","spread":"4.26"},{"groupId":"OG001","value":"-2.11","spread":"5.41"},{"groupId":"OG002","value":"-4.42","spread":"5.70"},{"groupId":"OG003","value":"-5.71","spread":"5.85"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"BWL versus no BWL","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data.","pValue":"0.0001","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session."},{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"NB versus placebo","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data.","pValue":"0.63","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session."}]},{"type":"SECONDARY","title":"Number of Participants Meeting Response Criteria","description":"Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","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":"OG001","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":"OG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo"},{"id":"OG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"25"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Analyses used all available data.","nonInferiorityType":"SUPERIORITY","pValue":".004","statisticalMethod":"Chi-squared"}]}]},"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":"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","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":18,"otherNumAtRisk":31},{"id":"EG001","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","deathsNumAffected":0,"deathsNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"otherNumAffected":24,"otherNumAtRisk":27},{"id":"EG002","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling\n\nPlacebo: Placebo","deathsNumAffected":0,"deathsNumAtRisk":29,"seriousNumAffected":1,"seriousNumAtRisk":29,"otherNumAffected":20,"otherNumAtRisk":29},{"id":"EG003","title":"BWL + NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and 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\n\nBehavioral Weight Loss (BWL) counseling: BWL counseling","deathsNumAffected":0,"deathsNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"otherNumAffected":24,"otherNumAtRisk":31}],"seriousEvents":[{"term":"Hypertensive Crisis","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":31},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":29},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":31}]}],"otherEvents":[{"term":"Anxiety","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31},{"groupId":"EG001","numAffected":3,"numAtRisk":27},{"groupId":"EG002","numAffected":2,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":31}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31},{"groupId":"EG001","numAffected":11,"numAtRisk":27},{"groupId":"EG002","numAffected":7,"numAtRisk":29},{"groupId":"EG003","numAffected":8,"numAtRisk":31}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31},{"groupId":"EG001","numAffected":3,"numAtRisk":27},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":4,"numAtRisk":31}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31},{"groupId":"EG001","numAffected":12,"numAtRisk":27},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":5,"numAtRisk":31}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31},{"groupId":"EG001","numAffected":16,"numAtRisk":27},{"groupId":"EG002","numAffected":4,"numAtRisk":29},{"groupId":"EG003","numAffected":11,"numAtRisk":31}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31},{"groupId":"EG001","numAffected":13,"numAtRisk":27},{"groupId":"EG002","numAffected":9,"numAtRisk":29},{"groupId":"EG003","numAffected":11,"numAtRisk":31}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31},{"groupId":"EG001","numAffected":11,"numAtRisk":27},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":6,"numAtRisk":31}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31},{"groupId":"EG001","numAffected":13,"numAtRisk":27},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":8,"numAtRisk":31}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31},{"groupId":"EG001","numAffected":1,"numAtRisk":27},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":2,"numAtRisk":31}]}]},"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":"2020-10-28","uploadDate":"2022-07-18T16:56","filename":"Prot_SAP_000.pdf","size":801639}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2022-08-18","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 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