[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623574":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":20,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":20,"overallStatus":88,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Yale University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"MHBC Intervention Group","EXPERIMENTAL","Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone\u002FBupropion).",[13,14,15],"Drug: Naltrexone hydrochloride","Drug: Bupropion Hydrochloride Extended-release","Behavioral: Cognitive-Behavioral Therapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Control Group","NO_INTERVENTION","Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.",null,[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"DRUG","Naltrexone hydrochloride","Participants will be given 50mg\u002Fday of Naltrexone for 4 months.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":20},"Bupropion Hydrochloride 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":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":20},"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],[37],{"name":38,"affiliation":5,"role":39},"Caitlin E Smith, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":20,"email":44},"CONTACT","203-785-7210","caitlin.smith@yale.edu",[46],{"facility":5,"status":20,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"New Haven","Connecticut","06511","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-72.92816,41.30815,{"lat":56,"lon":55},[59],{"name":38,"role":42,"phone":43,"phoneExt":20,"email":44},{"type":61,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[63],{"name":64,"class":65},"National Institute on Drug Abuse (NIDA)","NIH","100623574","phase-1-a-multiple-health-behavior-change-mhbc-intervention-for-weight-loss-and-smoking-cessation-for-pre-bariatric-surgery-patients-100623574",false,"NCT07398404","A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients","Inclusion Criteria:\n\n* Be 18-65 years old.\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* 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 an acute medical or psychiatric disorder that would make participation difficult or unsafe.\n* Has suicidal or homicidal ideation that requires immediate attention.\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 evidence of a second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram that would preclude safe participation.\n* Has stage 2 hypertension (blood pressure greater than 160\u002F100 or heart rate over 100 beats\u002Fminute).\n* Has elevated bilirubin test or any other liver function test value \\> 5 times the upper limit of normal laboratory criteria.\n* Has a platelet count \\\u003C 100x10 3\u002FuL.\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 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, including cancer.\n* Has angle closure glaucoma.\n* Has taken an investigational drug in another study within 30 days of study consent.\n* Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.\n* Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.\n* Is receiving ongoing treatment with tricyclic antidepressants, xanthines, systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous stimulants, or any medication that could interact adversely with the study medications.\n* Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.\n* Requires treatment with opioid-containing medications during the study period.\n* Has a surgery planned other than bariatric surgery.\n* Is currently in jail, prison, or any inpatient overnight facility as required by a court of law or have pending legal action or other legal situation that could prevent participation.\n* Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.","ALL","18 Years","65 Years",{"count":77,"type":78},64,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.",[85,86,87],"Obesity","Smoking Cessation","Bariatric Surgery Patients","NOT_YET_RECRUITING","2026-03-17",{"date":91,"type":92},"2026-03-20","ACTUAL",{"date":94,"type":78},"2026-07-01",{"date":96,"type":78},"2031-06-30",{"name":5,"class":6},1]