Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
NCT07224087 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-19
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.
Conditions
- Obesity
- Smoking Cessation
- Bariatric Surgery Patients
Interventions
- 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.
Sponsors & Collaborators
-
American Society for Metabolic and Bariatric Surgery
collaborator OTHER -
Yale University
lead OTHER
Principal Investigators
-
Caitlin E Smith, PhD · Yale University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-02
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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