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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Pre-bariatric surgery patients would significantly benefit from a tailored multiple health behavior change intervention targeting weight loss and smoking cessation concurrently, yet no such interventions have been examined within this patient population. This study aims to develop and pilot a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone + Bupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot will evaluate the feasibility and acceptability of the intervention, as well as use a mixed methods approach for intervention refinement. Weight loss and smoking cessation will be assessed post-treatment. This study will provide important preliminary data needed to develop an effective intervention that will address weight loss and smoking cessation concurrently, which is needed to improve bariatric surgery utilization and reduce risk for smoking relapse post-surgery for this high-risk patient population.

Conditions

• Obesity
• Smoking Cessation
• Bariatric Surgery Patients

Interventions

Type	Name	Description
DRUG	Naltrexone Hydrochloride	Participants will be given 50mg/day of Naltrexone for 4 months.
DRUG	Bupropion HCl Extended Release	Participants will be given 300mg/day of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon/early evening).
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.

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-11-03
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study