Smoking in bariatric surgery: a systematic review.
Alexandra Chow, Amy Neville, Nicole Kolozsvari
https://pubmed.ncbi.nlm.nih.gov/32524412Actively Recruiting
Phase 1
Age: 18Years - 65Years
All Genders
ID07224087
Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Led by Yale University · Updated on 2026-03-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
A
American Society for Metabolic and Bariatric Surgery
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new intervention aimed at helping adults seeking bariatric surgery to lose weight and quit smoking at the same time. This study focuses on patients who often face the challenge that quitting smoking can lead to weight gain, which complicates their surgery preparation. The study is a Phase 1 pilot to develop and test the feasibility and acceptability of a combined medication and behavioral therapy approach tailored for this group. Participants will receive a multiple health behavior change intervention involving medication and cognitive-behavioral therapy for four months. The medication includes daily doses of Naltrexone (50 mg) and Bupropion Extended Release (300 mg, taken twice daily). Alongside the medication, participants will attend weekly 60-minute sessions of cognitive-behavioral therapy focused on weight loss and smoking cessation. During the study, participants will be monitored for treatment adherence and outcomes including weight change and smoking cessation at multiple time points up to 16 weeks. Assessments include exhaled carbon monoxide tests, interviews, questionnaires on nicotine dependence, depression symptoms, and physical activity. The study aims to gather preliminary data on how well the intervention works and how acceptable it is to patients preparing for bariatric surgery.
CONDITIONS
Brief Title
Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Be actively considering bariatric surgery
- Smoke at least 5 cigarettes daily for the past 3 months
- Have a BMI of 30.0 kg/m2 or higher
- Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines)
- No history of medical conditions contraindicated with Naltrexone or Bupropion (e.g., seizure disorders, uncontrolled hypertension, heart attacks, heart disease, stroke, anorexia, bulimia)
- Physically well enough to participate (e.g., able to walk independently)
- Speak, read, and write in English
- Be between 18 and 65 years old
- Not currently pregnant or breastfeeding and have no plans to become pregnant or breastfeed during the study
- No active suicidal or homicidal thoughts
You will not qualify if you...
- Predisposition to seizures or history of seizure disorders
- History of anorexia nervosa or bulimia nervosa
- Currently taking medications contraindicated with Naltrexone or Bupropion (e.g., MAOIs, opiates)
- Allergy or sensitivity to Naltrexone or Bupropion
- Co-existing psychiatric conditions needing hospitalization or intensive treatment (e.g., bipolar disorder, psychotic illness, severe depression)
- Untreated high blood pressure or high heart rate
- History of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or cerebrovascular disease including stroke
- Uncontrolled Type I or Type 2 diabetes
- History of severe kidney, liver, neurological, lung, gallbladder disease, or other unstable medical issues
- Currently pregnant, breastfeeding, or not using reliable birth control
- Active suicidal or homicidal ideation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - 4 months
Participants receive a multiple health behavior change intervention combining medication (Naltrexone and Bupropion) and cognitive-behavioral therapy for weight loss and smoking cessation.
Weekly visits for 60-minute therapy sessions
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Loading map...
Research Team
C
Caitlin E Smith, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here