A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT07398404
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Bariatric Surgery Patients
- Obesity
- Smoking Cessation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Naltrexone hydrochloride — DRUGParticipants will be given 50mg/day of Naltrexone for 4 months.
- Bupropion Hydrochloride Extended-release — DRUGParticipants 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).
- Cognitive-Behavioral Therapy — BEHAVIORALParticipants 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.
Study Details
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.
Key Dates
- First listed
- Feb 9, 2026
- Start date
- Sep 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2030
- Completion
- Jun 30, 2031
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: MHBC Intervention GroupParticipants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
- No Intervention: Control GroupParticipants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.
Primary Outcome Measure
Study enrollment to assess Feasibility [ Time Frame: 16 weeks ]
Central Contacts
- Caitlin E Smith, PhD203-785-7210
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29407 |
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