{"protocolSection":{"identificationModule":{"nctId":"NCT04605081","orgStudyIdInfo":{"id":"2000029057a"},"secondaryIdInfos":[{"id":"5R01DK126637-02","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01DK126637-02"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)","officialTitle":"Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)"},"statusModule":{"statusVerifiedDate":"2026-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-06-10","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":"2020-10-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-07-10","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 test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo."},"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":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Naltrexone+Bupropion Medication","type":"EXPERIMENTAL","interventionNames":["Drug: Naltrexone and Bupropion (NB) medication"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Naltrexone and Bupropion (NB) medication","description":"NB medication will be taken daily in pill form.","armGroupLabels":["Naltrexone+Bupropion Medication"],"otherNames":["Contrave"]},{"type":"OTHER","name":"Placebo","description":"Placebo will be inactive and taken daily in pill form.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Loss-of-control Eating Relapse","description":"Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.","timeFrame":"At post-treatment after the 12-week treatment"},{"measure":"Loss-of-control Eating Relapse","description":"Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.","timeFrame":"From post-treatment to the 6-month follow-up"},{"measure":"Loss-of-control Eating Relapse","description":"Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.","timeFrame":"From post-treatment to the 12-month follow-up"},{"measure":"Percent Weight Change","description":"Percent weight loss is calculated based on change from pre-treatment to post-treatment at 12 weeks. 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Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).","timeFrame":"6-month follow-up after the end of treatment"},{"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":"12-month follow-up after the end of treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Be in the age range ≥18 years of age and ≤70 years of age.\n* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy\n* Approximately ten months post-surgery\n* Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment responders to a four-month treatment trial of medication and/or BWL\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 15 months (3-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":{"overallOfficials":[{"name":"Valentina Ivezaj, Ph.D.","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale School of Medicine","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":"Naltrexone+Bupropion Medication","description":"NB medication will be taken daily in pill form for twelve weeks."},{"id":"FG001","title":"Placebo","description":"Placebo will be inactive and taken daily in pill form for twelve weeks."}],"periods":[{"title":"Overall 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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":"4"},{"groupId":"BG002","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"18"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Loss-of-control Eating Relapse","description":"Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder 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