[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610169":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":57,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":22,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Yale University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants will receive the multiple health behavior change intervention with combined medication (Naltrexone 50mg\u002Fday; Bupropion Extended Release 300mg\u002Fday) and behavior therapy (Cognitive-Behavioral Therapy) for 4 months.",[13,14,15],"Drug: Naltrexone Hydrochloride","Drug: Bupropion HCl Extended Release","Behavioral: Cognitive-Behavioral Therapy",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Naltrexone Hydrochloride","Participants will be given 50mg\u002Fday of Naltrexone for 4 months.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Bupropion HCl Extended Release","Participants will be given 300mg\u002Fday of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon\u002Fearly evening).",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"BEHAVIORAL","Cognitive-Behavioral Therapy","Participants will receive cognitive-behavioral therapy for weight loss and smoking cessation. Participants will meet with their assigned study clinician weekly for 60 minutes for 4 months.",[9],[33],{"name":34,"affiliation":5,"role":35},"Caitlin E Smith, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":22,"email":40},"CONTACT","203-785-7210","caitlin.smith@yale.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-72.92816,41.30815,{"lat":53,"lon":52},[56],{"name":34,"role":38,"phone":39,"phoneExt":22,"email":40},{"type":58,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[60],{"name":61,"class":6},"American Society for Metabolic and Bariatric Surgery","100610169","phase-1-development-of-a-mhbc-intervention-for-weight-loss-and-smoking-cessation-for-pre-bariatric-surgery-patients-100610169",false,"NCT07224087","Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","Inclusion Criteria:\n\n* Be actively considering bariatric surgery.\n* Smoke at least 5 cigarettes daily for the past 3 months.\n* Have a BMI ≥ 30.0 kg\u002Fm2.\n* Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines).\n* No history of medical conditions that are contraindicated with Naltrexone or Bupropion (e.g., seizure disorders, uncontrolled hypertension, cardiac issues including history of heart attacks, heart disease, or stroke, history of anorexia or bulimia nervosa).\n* Physically well enough to participate in the intervention (e.g., able to walk independently).\n* Speak\u002Fread\u002Fwrite in English.\n* Be 18-65 years old.\n* Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.\n* No active suicidal or homicidal ideation.\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 contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).\n* Has a history of allergy or sensitivity to Naltrexone or Bupropion.\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\u002Fminute.\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 Type I or Type 2 diabetes mellitus.\n* Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder.\n* Is breast-feeding or is pregnant or is not using a reliable form of birth control.\n* Reports active suicidal or homicidal ideation.","ALL","18 Years","65 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","The purpose of this research study is to develop and pilot a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery.",[80,81,82],"Obesity","Smoking Cessation","Bariatric Surgery Patients","2026-03-16",{"date":85,"type":86},"2026-03-19","ACTUAL",{"date":88,"type":86},"2026-03-02",{"date":90,"type":74},"2027-12-31",{"name":5,"class":6},1]