NCT07224087 Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
| NCT ID | NCT07224087 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Be actively considering bariatric surgery. * Smoke at least 5 cigarettes daily for the past 3 months. * Have a BMI ≥ 30.0 kg/m2. * 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/read/write in English. * Be 18-65 years old. * Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study. * No active suicidal or homicidal ideation. Exclusion Criteria: * Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovasc
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