{"protocolSection":{"identificationModule":{"nctId":"NCT03063606","orgStudyIdInfo":{"id":"1506016065-S"},"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: Specialist Treatment","officialTitle":"Behavioral and Pharmacologic Treatment of Binge Eating and Obesity"},"statusModule":{"statusVerifiedDate":"2024-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2017-09-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-12-01","type":"ACTUAL"},"completionDateStruct":{"date":"2022-12-16","type":"ACTUAL"},"studyFirstSubmitDate":"2017-02-03","studyFirstSubmitQcDate":"2017-02-20","studyFirstPostDateStruct":{"date":"2017-02-24","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-11-30","resultsFirstSubmitQcDate":"2023-06-14","resultsFirstPostDateStruct":{"date":"2023-07-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-01-03","lastUpdatePostDateStruct":{"date":"2024-02-01","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 of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .","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 (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy)."},"conditionsModule":{"conditions":["Binge-Eating Disorder","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":31,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cognitive-Behavioral Therapy (CBT)","type":"EXPERIMENTAL","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.","interventionNames":["Behavioral: Cognitive-Behavioral Therapy (CBT)","Drug: NB Medication (on-going from acute treatment)"]},{"label":"Naltrexone/bupropion (NB) (on-going from acute stage)","type":"ACTIVE_COMPARATOR","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.","interventionNames":["Drug: NB Medication (on-going from acute treatment)"]}],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive-Behavioral Therapy (CBT)","description":"CBT specialist treatment","armGroupLabels":["Cognitive-Behavioral Therapy (CBT)"]},{"type":"DRUG","name":"NB Medication (on-going from acute treatment)","description":"Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)","armGroupLabels":["Cognitive-Behavioral Therapy (CBT)","Naltrexone/bupropion (NB) (on-going from acute stage)"],"otherNames":["Contrave"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Binge Eating Frequency (Continuous)","description":"Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.","timeFrame":"Post-treatment (4 months)"},{"measure":"Change in Body Mass Index at 4 Months Post-Treatment From Baseline","description":"BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline","timeFrame":"Baseline and Post-treatment (4 months)"}],"secondaryOutcomes":[{"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":"6-Month Follow-up"},{"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":"12-Month Follow-up"}],"otherOutcomes":[{"measure":"Body Mass Index","description":"BMI is calculated using measured height and weight (e.g., percent loss).","timeFrame":"12-Month Follow-up"},{"measure":"Body Mass Index","description":"BMI is calculated using measured height and weight (e.g., percent loss).","timeFrame":"6-Month Follow-up"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Participated in acute treatment for binge-eating disorder and obesity;\n* Did not have 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 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 M 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}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This study is part of a larger RCT (NCT03045341). In this study, we randomized participants who were non-responders to acute treatment to receive either CBT or no CBT. They continued the pharmacotherapy from the earlier treatment. Because of this study design, we report results based on the primary aim of the study (CBT vs no CBT). Also because of this study design, we report adverse events that were systematically assessed as potentially related to the pharmacotherapy (not to CBT).","groups":[{"id":"FG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"FG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"BG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"31"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.2","spread":"13.6"},{"groupId":"BG001","value":"45.1","spread":"12.7"},{"groupId":"BG002","value":"46.3","spread":"13.1"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Sex/Gender","categories":[{"title":"Male","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"}]},{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"24"}]},{"title":"Transgender","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"27"}]},{"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":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"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":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"25"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Binge Eating Frequency (Continuous)","description":"Binge eating assessed by interview and reported as frequency in the past 28 days. Frequency is defined continuously.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Eating events/28 days","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.6"},{"groupId":"OG001","value":"12.1","spread":"9.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Analyses used all available data. Analyses to compare treatments were all intent-to-treat.","pValue":".0002","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses were performed for all randomized patients who attended the first treatment session."}]},{"type":"PRIMARY","title":"Change in Body Mass Index at 4 Months Post-Treatment From Baseline","description":"BMI is calculated using measured height and weight. We report percent of baseline weight. Negative values indicate weight loss. Calculated by value at 4 months minus value at baseline","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Kg/m^2","timeFrame":"Baseline and Post-treatment (4 months)","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","spread":"4.27"},{"groupId":"OG001","value":"-1.18","spread":"4.35"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":".83","pValueComment":"Analyses used all available data. Analyses to compare treatments were all intent-to-treat.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Analyses were performed for all randomized patients who attended the first treatment session."}]},{"type":"SECONDARY","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":"eating events/28 days","timeFrame":"6-Month Follow-up","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"1"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.80","spread":"6.56"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","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).","populationDescription":"No participants in the on-going blinded pharmacotherapy group completed the 12-month follow-up assessment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"eating events/28 days","timeFrame":"12-Month Follow-up","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.70","spread":"2.54"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Body Mass Index","description":"BMI is calculated using measured height and weight (e.g., percent loss).","populationDescription":"There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.","reportingStatus":"POSTED","timeFrame":"12-Month Follow-up","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Body Mass Index","description":"BMI is calculated using measured height and weight (e.g., percent loss).","populationDescription":"There were too many missing data to produce reliable calculations and therefore these data were not produced as part of the study.","reportingStatus":"POSTED","timeFrame":"6-Month Follow-up","groups":[{"id":"OG000","title":"Cognitive-Behavioral Therapy (CBT) Plus On-going Blinded Pharmacotherapy","description":"CBT is a \"specialist\" focal treatment with three overlapping phases. (1) Establishing a collaborative therapeutic relationship while focusing on educating patients about the nature of binge eating and factors thought to maintain the problem. Specific behavioral strategies (e.g., self-monitoring) are used to help patients identify problematic eating behaviors while establishing a normal structured eating pattern. (2) Integrating cognitive restructuring procedures, focusing on helping patients learn to identify and challenge maladaptive cognitions regarding eating and weight/shape and thoughts that trigger binge eating. (3) Maintaining change and preventing relapse.\n\nCognitive-Behavioral Therapy (CBT): CBT specialist treatment\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"},{"id":"OG001","title":"On-going Blinded Pharmacotherapy","description":"Participants will continue acute blinded pharmacotherapy (consisting of either naltrexone/bupropion combination or placebo), but without added cognitive-behavioral therapy.\n\nNB Medication (on-going from acute treatment): Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Month 1","description":"Participants were interviewed for nonserious adverse events listed as \\>5% on the package insert for NB at month 1. Adverse event assessment was for ongoing pharmacotherapy, not based on CBT. Thus, numbers of participants affected and at risk reflect ongoing pharmacotherapy data. Adverse events expected to stem from CBT were not assessed systematically. Arms reported reflect ongoing NB and placebo pharmacotherapy, not CBT.","eventGroups":[{"id":"EG000","title":"On-going Blinded Pharmacotherapy (NB)","description":"On-going from acute treatment, consisting of naltrexone/bupropion combination","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":3,"otherNumAtRisk":15},{"id":"EG001","title":"On-going Blinded Pharmacotherapy (Placebo)","description":"On-going from acute treatment, consisting of placebo","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":5,"otherNumAtRisk":16}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":16}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":16}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":2,"numAtRisk":16}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":0,"numAtRisk":16}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":16}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":16}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":3,"numAtRisk":16}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":15},{"groupId":"EG001","numAffected":1,"numAtRisk":16}]}]},"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":"2022-11-22T14:30","filename":"Prot_SAP_000.pdf","size":801334}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","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":"D015928","term":"Cognitive Behavioral Therapy"},{"id":"C000591595","term":"bupropion hydrochloride, naltrexone hydrochoride drug combination"}],"ancestors":[{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":true}