NCT07224087Not yet recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Obesity
- NCT number
- NCT07224087
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).
Other illness
- Has a history of anorexia nervosa or history of bulimia nervosa.
- 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 untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
- 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.
Other
- Is breast-feeding or is pregnant or is not using a reliable form of birth control.
- Reports active suicidal or homicidal ideation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.