{"protocolSection":{"identificationModule":{"nctId":"NCT04599478","orgStudyIdInfo":{"id":"2000029057"},"secondaryIdInfos":[{"id":"R01DK126637-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DK126637-01"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)","officialTitle":"Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)"},"statusModule":{"statusVerifiedDate":"2026-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-06-29","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2026-06-04","type":"ACTUAL"},"completionDateStruct":{"date":"2026-06-04","type":"ACTUAL"},"studyFirstSubmitDate":"2020-10-21","studyFirstSubmitQcDate":"2020-10-21","studyFirstPostDateStruct":{"date":"2020-10-22","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-07-09","resultsFirstSubmitQcDate":"2026-08-04","resultsFirstPostDateStruct":{"date":"2026-08-26","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-08-04","lastUpdatePostDateStruct":{"date":"2026-08-26","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,"isUsExport":false},"descriptionModule":{"briefSummary":"This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.","detailedDescription":"Participants who provide informed consent and are determined to be eligible will then participate in the study.\n\nA total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type."},"conditionsModule":{"conditions":["Loss-of-control Eating","Obesity/Overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":92,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication","type":"EXPERIMENTAL","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.","interventionNames":["Drug: Naltrexone and Bupropion medication","Behavioral: Behavioral Weight Loss"]},{"label":"BWL + Placebo","type":"EXPERIMENTAL","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.","interventionNames":["Behavioral: Behavioral Weight Loss","Other: Placebo"]},{"label":"NB medication","type":"EXPERIMENTAL","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.","interventionNames":["Drug: Naltrexone and Bupropion medication"]},{"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":"Naltrexone and Bupropion medication","description":"NB medication will be taken daily in pill form.","armGroupLabels":["Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication","NB medication"],"otherNames":["Contrave"]},{"type":"BEHAVIORAL","name":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL) counseling includes weekly sessions.","armGroupLabels":["BWL + Placebo","Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication"]},{"type":"OTHER","name":"Placebo","description":"Placebo will be inactive and taken daily in pill form.","armGroupLabels":["BWL + Placebo","Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Loss-of-control Eating Frequency","description":"Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.","timeFrame":"Post-treatment (4 months)"},{"measure":"Percent Weight Loss","description":"Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.","timeFrame":"Post-treatment (4 months)"}],"secondaryOutcomes":[{"measure":"Number of Participants With Loss-of-control Eating Remission","description":"Categorical: zero episodes/28 days","timeFrame":"Post-treatment (4 months)"},{"measure":"Number of Participants With 5% Weight Loss","description":"Categorical: 5% weight loss","timeFrame":"Post-treatment (4 months)"},{"measure":"Eating Disorder Psychopathology","description":"Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).","timeFrame":"Post-treatment (4 months)"},{"measure":"Depressive Symptoms","description":"Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).","timeFrame":"Post-treatment (4 months)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Be in the age range ≥18 years of age and ≤70 years of age.\n* Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50\n* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy\n* Approximately six months post-surgery\n* Experience regular loss-of-control eating (defined as at least once weekly over the past 28 days)\n* Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).\n* Read, comprehend, and write English at a sufficient level to complete study-related materials.\n* Provide a signed and dated written informed consent prior to study participation.\n\nBe available for participation in the study for up to 19 months (7-month treatment plus 12-month follow up).\n\nExclusion Criteria:\n\n* Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).\n* Has a history of anorexia nervosa or history of bulimia nervosa.\n* Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).\n* Is currently using other medications for weight loss.\n* Has a history of allergy or sensitivity to bupropion or naltrexone.\n* Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)\n* Has untreated hypertension with a seated systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg, or heart rate \\> 100 beats/minute.\n* Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.\n* Has current uncontrolled hypertension.\n* Has current uncontrolled Type I or Type II diabetes mellitus.\n* Has untreated hypothyroidism with a TSH \\> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.\n* Has gallbladder disease.\n* Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.\n* Has a recent history of drug or alcohol dependence (since having bariatric surgery).\n* Is currently in active treatment for eating or weight loss.\n* Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.\n* Is breast-feeding or is pregnant or is not using a reliable form of birth control.\n* Reports active suicidal or homicidal ideation.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Yale Department of Psychiatry","city":"New Haven","state":"Connecticut","zip":"06510","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"FG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"FG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"FG003","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."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"24"},{"groupId":"FG003","numSubjects":"22"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"19"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"7"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"BG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"BG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"BG003","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."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"92"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45.42","spread":"10.54"},{"groupId":"BG001","value":"48.64","spread":"9.63"},{"groupId":"BG002","value":"47.67","spread":"9.54"},{"groupId":"BG003","value":"45.32","spread":"12.41"},{"groupId":"BG004","value":"46.75","spread":"10.49"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"22"},{"groupId":"BG004","value":"80"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"12"}]}]}]},{"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":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]},{"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":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"26"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"65"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"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":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"17"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"17"},{"groupId":"BG004","value":"75"}]},{"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"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Loss-of-control Eating Frequency","description":"Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"episodes per the past 28 days","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.71","spread":"3.05"},{"groupId":"OG001","value":"5.33","spread":"6.49"},{"groupId":"OG002","value":"5.58","spread":"7.07"},{"groupId":"OG003","value":"10.73","spread":"11.85"}]}]}]},{"type":"PRIMARY","title":"Percent Weight Loss","description":"Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.19","spread":"4.70"},{"groupId":"OG001","value":"-1.74","spread":"4.42"},{"groupId":"OG002","value":"-3.94","spread":"4.98"},{"groupId":"OG003","value":"-1.36","spread":"4.86"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Loss-of-control Eating Remission","description":"Categorical: zero episodes/28 days","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"5"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With 5% Weight Loss","description":"Categorical: 5% weight loss","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"22"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"9"}]}]}]},{"type":"SECONDARY","title":"Eating Disorder Psychopathology","description":"Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale ranging from 0-6","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"0.68"},{"groupId":"OG001","value":"1.34","spread":"0.85"},{"groupId":"OG002","value":"1.44","spread":"0.89"},{"groupId":"OG003","value":"1.74","spread":"0.86"}]}]}]},{"type":"SECONDARY","title":"Depressive Symptoms","description":"Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale ranging from 0-27","timeFrame":"Post-treatment (4 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form."},{"id":"OG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form."},{"id":"OG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form."},{"id":"OG003","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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.19","spread":"3.25"},{"groupId":"OG001","value":"3.93","spread":"3.01"},{"groupId":"OG002","value":"3.23","spread":"3.51"},{"groupId":"OG003","value":"3.77","spread":"4.11"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From enrollment until end of treatment, up to 16 weeks","description":"The denominator is based on adverse events data collected and excludes participants who dropped without any follow-up","eventGroups":[{"id":"EG000","title":"Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.","deathsNumAffected":0,"deathsNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":16,"otherNumAtRisk":21},{"id":"EG001","title":"BWL + Placebo","description":"Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.","deathsNumAffected":0,"deathsNumAtRisk":17,"seriousNumAffected":0,"seriousNumAtRisk":17,"otherNumAffected":14,"otherNumAtRisk":17},{"id":"EG002","title":"NB Medication","description":"Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.","deathsNumAffected":0,"deathsNumAtRisk":23,"seriousNumAffected":0,"seriousNumAtRisk":23,"otherNumAffected":22,"otherNumAtRisk":23},{"id":"EG003","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.","deathsNumAffected":0,"deathsNumAtRisk":22,"seriousNumAffected":0,"seriousNumAtRisk":22,"otherNumAffected":12,"otherNumAtRisk":22}],"otherEvents":[{"term":"Abdominal Pain","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":3,"numAtRisk":17},{"groupId":"EG002","numAffected":4,"numAtRisk":23},{"groupId":"EG003","numAffected":4,"numAtRisk":22}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21},{"groupId":"EG001","numAffected":5,"numAtRisk":17},{"groupId":"EG002","numAffected":12,"numAtRisk":23},{"groupId":"EG003","numAffected":5,"numAtRisk":22}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21},{"groupId":"EG001","numAffected":3,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":2,"numAtRisk":22}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":9,"numAtRisk":23},{"groupId":"EG003","numAffected":1,"numAtRisk":22}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":22}]},{"term":"Anxiety","organSystem":"Psychiatric 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