[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07398404":3,"trial-entities:NCT07398404":162,"trial-summary:NCT07398404":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":77,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":133,"locations":136,"central_contacts":151,"overall_officials":153,"references":156,"see_also_links":161},"NCT07398404","2000041823","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","NOT_YET_RECRUITING","2031-06-30","2026-07","2026-07-08","2026-09-01","Medical University of South Carolina","OTHER",true,"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.","Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. This study aims to evaluate a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone\u002FBupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot randomized control trial will evaluate feasibility and acceptability of the intervention and compare the intervention to a standard of care control group.",[19,20,21],"Obesity","Smoking Cessation","Bariatric Surgery Patients",[],"INTERVENTIONAL","TREATMENT",[26,27],"PHASE1","PHASE2",{"count":29,"type":30},64,"ESTIMATED",[32,38,42],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Naltrexone hydrochloride","Participants will be given 50mg\u002Fday of Naltrexone for 4 months.",[37],"MHBC Intervention Group",{"type":33,"name":39,"description":40,"armGroupLabels":41},"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).",[37],{"type":43,"name":44,"description":45,"armGroupLabels":46},"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.",[37],[48,52,55,58,62,66,70,74],{"measure":49,"description":50,"timeFrame":51},"Study enrollment to assess Feasibility","Number of participants enrolled out of participants screened.","16 weeks",{"measure":53,"description":54,"timeFrame":51},"Mean number treatment sessions attended to assess Feasibility","Mean number of treatment sessions attended.",{"measure":56,"description":57,"timeFrame":51},"Retention to assess Feasibility","Retention will be measured as the percent of participants that attend the post treatment assessment.",{"measure":59,"description":60,"timeFrame":61},"Treatment credibility to assess Acceptability","Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility).","Week 4, Week 8, Week 12, Week 16",{"measure":63,"description":64,"timeFrame":65},"Treatment satisfaction to assess Acceptability","Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction).","Week 16",{"measure":67,"description":68,"timeFrame":69},"Percent weight change","Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.","Baseline, Week 16, 6-month follow-up",{"measure":71,"description":72,"timeFrame":73},"Smoking cessation, as measured by exhaled carbon monoxide","Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.","Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up",{"measure":75,"description":76,"timeFrame":73},"Smoking cessation, as measured by timeline followback interview","Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.",[78,81,84,87],{"measure":79,"description":80,"timeFrame":69},"Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence","The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence.",{"measure":82,"description":83,"timeFrame":69},"Depressive symptomatology, as measured by the Patient Health Questionnaire-9","The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.",{"measure":85,"description":86,"timeFrame":69},"Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)","GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calculated in METs-minutes per day. Participants are classified as \"active\" if they meet or exceed 600 METs-minutes per week.",{"measure":88,"description":89,"timeFrame":90},"Number of participants with Bariatric surgery completion","Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.","6-month follow-up","ALL","18 Years","65 Years",false,{"inclusion":96,"exclusion":107,"raw_text":132},[97,98,99,100,101,102,103,104,105,106],"Be 18-65 years old.","Be actively considering bariatric surgery.","Smoke at least 5 cigarettes daily for the past 3 months.","Have a BMI ≥ 30.0 kg\u002Fm2.","Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines).","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).","Physically well enough to participate in the intervention (e.g., able to walk independently).","Speak\u002Fread\u002Fwrite in English.","Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.","No active suicidal or homicidal ideation.",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Has an acute medical or psychiatric disorder that would make participation difficult or unsafe.","Has suicidal or homicidal ideation that requires immediate attention.","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).","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.","Has stage 2 hypertension (blood pressure greater than 160\u002F100 or heart rate over 100 beats\u002Fminute).","Has elevated bilirubin test or any other liver function test value \\> 5 times the upper limit of normal laboratory criteria.","Has a platelet count \\\u003C 100x10 3\u002FuL.","Has a history of anorexia nervosa or history of bulimia nervosa.","Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).","Has a history of allergy or sensitivity to Naltrexone or Bupropion.","Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression).","Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.","Has current uncontrolled Type I or Type 2 diabetes mellitus.","Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder, including cancer.","Has angle closure glaucoma.","Has taken an investigational drug in another study within 30 days of study consent.","Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.","Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.","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.","Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.","Requires treatment with opioid-containing medications during the study period.","Has a surgery planned other than bariatric surgery.","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.","Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.","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.",[134,135],"ADULT","OLDER_ADULT",[137],{"facility":13,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":148},"Charleston","South Carolina","29407","United States",[143],{"name":144,"role":145,"phone":146,"email":147},"Caitlin E Smith, PhD","CONTACT","203-785-7210","smithcai@musc.edu",{"lat":149,"lon":150},32.77632,-79.93275,[152],{"name":144,"role":145,"phone":146,"email":147},[154],{"name":144,"affiliation":13,"role":155},"PRINCIPAL_INVESTIGATOR",[157],{"pmid":158,"type":159,"citation":160},"32524412","BACKGROUND","Chow A, Neville A, Kolozsvari N. Smoking in bariatric surgery: a systematic review. Surg Endosc. 2021 Jun;35(6):3047-3066. doi: 10.1007\u002Fs00464-020-07669-3. Epub 2020 Jun 10.",[],{"nct_id":4,"conditions":163,"biomarkers":164},[19],[],{"nct_id":4,"found":15,"summary":166,"prompt_version":176},{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is a pilot randomized control trial aiming to enroll 64 participants. It compares the intervention to a standard of care control group.","completed","Weight Loss and Smoking Cessation for Bariatric Surgery Patients","This study is testing a new approach for people considering weight-loss surgery (bariatric surgery) who also smoke. It combines two medications, Naltrexone hydrochloride and Bupropion Hydrochloride Extended-release, with weekly counseling (cognitive-behavioral therapy) to help with both weight loss and quitting smoking. You might be able to join if you are 18-65 years old, actively thinking about bariatric surgery, smoke at least 5 cigarettes daily, and have a BMI of 30 or higher. The main goal is to see if this combined approach is practical and acceptable, and how many people attend sessions and stay in the study over 16 weeks. The study status is currently unclear.","The primary goals are measured at 16 weeks, which is the duration of the intervention.",106,"Participants will take Naltrexone and Bupropion daily for 4 months. They will also meet with a study clinician weekly for 60 minutes for 4 months.","Not stated in the trial record.",[34,39,44],"v2"]