Combined medication and behavioral program to help people preparing for bariatric surgery quit smoking and lose weight.
Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
This pilot will try a combined medication (naltrexone + bupropion) and cognitive-behavioral program to help adults who smoke and are preparing for bariatric surgery lose weight and quit smoking.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07224087 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pilot combines extended-release bupropion plus naltrexone with cognitive-behavioral therapy to target smoking cessation and preoperative weight loss in adults seeking bariatric surgery. Participants who smoke at least 5 cigarettes per day and have BMI ≥30 will receive the medication regimen alongside behavioral sessions, and outcomes will include feasibility, acceptability, weight change, and smoking abstinence after treatment. The study uses mixed methods—quantitative measures and qualitative feedback—to refine the intervention. Results will provide preliminary data to guide larger trials and address the common problem of post-cessation weight gain in this population.
Who should consider this trial
Good fit: Adults 18–65 who are actively considering bariatric surgery, smoke at least 5 cigarettes per day, have BMI ≥30 kg/m2, can take naltrexone and bupropion, and can attend visits in English are the intended participants.
Not a fit: People with contraindications to naltrexone or bupropion (for example, seizure disorders, current opioid use, uncontrolled hypertension), those who are pregnant or breastfeeding, non-smokers, or those not planning bariatric surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could help more candidates reach pre-surgery weight targets and stop smoking, lowering surgical risk and reducing chances of relapse after bariatric surgery.
How similar studies have performed: Components of the approach—bupropion for smoking cessation and bupropion/naltrexone for weight loss—have shown effectiveness, but combining them with behavioral therapy specifically for pre-bariatric patients is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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, 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). * Has a history of anorexia nervosa or history of bulimia nervosa. * Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates). * 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. * Is breast-feeding or is pregnant or is not using a reliable form of birth control. * Reports active suicidal or homicidal ideation.
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Caitlin E Smith, PhD — Yale University
- Study coordinator: Caitlin E Smith, PhD
- Email: caitlin.smith@yale.edu
- Phone: 203-785-7210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.