{"protocolSection":{"identificationModule":{"nctId":"NCT04662801","orgStudyIdInfo":{"id":"2000029491"},"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Weight Regain Treatment Post-Bariatric Surgery","officialTitle":"A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study"},"statusModule":{"statusVerifiedDate":"2023-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-08-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-09-13","type":"ACTUAL"},"completionDateStruct":{"date":"2022-09-13","type":"ACTUAL"},"studyFirstSubmitDate":"2020-12-09","studyFirstSubmitQcDate":"2020-12-09","studyFirstPostDateStruct":{"date":"2020-12-10","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-10-19","resultsFirstSubmitQcDate":"2023-10-19","resultsFirstPostDateStruct":{"date":"2023-11-13","type":"ACTUAL"},"dispFirstSubmitDate":"2023-09-05","dispFirstPostDateStruct":{"date":"2023-09-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-10-19","lastUpdatePostDateStruct":{"date":"2023-11-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Yale University","class":"OTHER"},"collaborators":[{"name":"American Psychological Foundation","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery."},"conditionsModule":{"conditions":["Obesity, Overweight"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":26,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Behavioral Weight Loss","type":"EXPERIMENTAL","interventionNames":["Behavioral: Behavioral Weight Loss (BWL)","Behavioral: Early Responder: BWL continued"]},{"label":"Behavioral Weight Loss + Medication","type":"EXPERIMENTAL","interventionNames":["Behavioral: Behavioral Weight Loss (BWL)","Combination Product: Early Non-responder: BWL continued with medication added"]}],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral Weight Loss (BWL)","description":"All participants will receive twelve weeks of BWL treatment.","armGroupLabels":["Behavioral Weight Loss","Behavioral Weight Loss + Medication"]},{"type":"BEHAVIORAL","name":"Early Responder: BWL continued","description":"Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.","armGroupLabels":["Behavioral Weight Loss"]},{"type":"COMBINATION_PRODUCT","name":"Early Non-responder: BWL continued with medication added","description":"Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.","armGroupLabels":["Behavioral Weight Loss + Medication"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Body Mass Index","description":"BMI is calculated using measured height and weight- kg/m2.","timeFrame":"Post-treatment (3 months)"}],"secondaryOutcomes":[{"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 (3 months)"},{"measure":"Food Craving","description":"Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.","timeFrame":"Post-treatment (3 months)"},{"measure":"Depressive Symptoms","description":"Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology","timeFrame":"Post-treatment (3 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 kg/m2\n* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy\n* Experiencing weight regain after bariatric surgery\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* Be available for participation in the study for up to 3 months.\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 University","city":"New Haven","state":"Connecticut","zip":"06511","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"FG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"BG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"51.17","spread":"11.01"},{"groupId":"BG001","value":"46.5","spread":"7.71"},{"groupId":"BG002","value":"49.05","spread":"9.73"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]},{"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":"0"},{"groupId":"BG002","value":"0"}]},{"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":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"16"}]},{"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"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Body Mass Index","description":"BMI is calculated using measured height and weight- kg/m2.","populationDescription":"Participants with complete data at follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m2","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"OG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.12","spread":"4.57"},{"groupId":"OG001","value":"40.48","spread":"4.89"}]}]}]},{"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).","populationDescription":"Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"OG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.53","spread":"0.80"},{"groupId":"OG001","value":"1.46","spread":"0.94"}]}]}]},{"type":"SECONDARY","title":"Food Craving","description":"Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.","populationDescription":"Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"OG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.65","spread":"0.49"},{"groupId":"OG001","value":"1.57","spread":"0.29"}]}]}]},{"type":"SECONDARY","title":"Depressive Symptoms","description":"Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology","populationDescription":"Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment (3 months)","groups":[{"id":"OG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment."},{"id":"OG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.89","spread":"5.21"},{"groupId":"OG001","value":"3.67","spread":"2.58"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Up to 3 months","description":"Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.","eventGroups":[{"id":"EG000","title":"Behavioral Weight Loss","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":0,"otherNumAtRisk":12},{"id":"EG001","title":"Behavioral Weight Loss + Medication","description":"Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.\n\nEarly Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":7,"otherNumAtRisk":10}],"otherEvents":[{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":4,"numAtRisk":10}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":5,"numAtRisk":10}]},{"term":"Dizziness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":5,"numAtRisk":10}]},{"term":"Headache","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":3,"numAtRisk":10}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":12},{"groupId":"EG001","numAffected":2,"numAtRisk":10}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr Valentina Ivezaj, Assistant Professor of Psychiatry","organization":"Yale School of Medicine","email":"valentina.ivezaj@yale.edu","phone":"+1 (203) 785-7807"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2021-11-30","uploadDate":"2023-10-19T09:00","filename":"Prot_SAP_000.pdf","size":312589}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D050177","term":"Overweight"}],"ancestors":[{"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"}]}},"hasResults":true}