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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Obesity; Bariatric Surgery Patients
• Intervention / Treatment: Drug: Naltrexone Hydrochloride; Drug: Bupropion HCl Extended Release; Behavioral: Cognitive-Behavioral Therapy

Detailed Description

Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. Pre-bariatric surgery patients would significantly benefit from a tailored multiple health behavior change intervention targeting weight loss and smoking cessation concurrently, yet no such interventions have been examined within this patient population.

This study aims to develop and pilot a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone + Bupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot will evaluate the feasibility and acceptability of the intervention, as well as use a mixed methods approach for intervention refinement. Weight loss and smoking cessation will be assessed post-treatment. This study will provide important preliminary data needed to develop an effective intervention that will address weight loss and smoking cessation concurrently, which is needed to improve bariatric surgery utilization and reduce risk for smoking relapse post-surgery for this high-risk patient population.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Caitlin E Smith, PhD; Phone Number: 203-785-7210; Email: caitlin.smith@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale University
      • Contact: Caitlin E Smith, PhD; Phone Number: 203-785-7210; Email: caitlin.smith@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Participants will receive the multiple health behavior change intervention with combined medication (Naltrexone 50mg/day; Bupropion Extended Release 300mg/day) and behavior therapy (Cognitive-Behavioral Therapy) for 4 months.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study enrollment to assess Feasibility	Number of participants enrolled out of participants screened	16 weeks
Mean number treatment sessions attended to assess Feasibility	Mean number of treatment sessions attended	16 weeks
Retention to assess Feasibility	Retention will be measured as the percent of participants that attend the post treatment assessment	16 weeks
Treatment credibility and satisfaction to assess Acceptability	Treatment credibility and satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is acceptable.	16 weeks
Percent weight change	Percent weight change will be calculated from baseline to post-treatment.	Baseline and Week 16
Smoking cessation, as measured by exhaled carbon monoxide	Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.	Baseline, Week 4, Week 8, Week 12, Week 16
Smoking cessation, as measured by timeline followback interview	Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.	Baseline, Week 4, Week 8, Week 12, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence	The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence.	Baseline and Week 16
Depressive symptomatology, as measured by the Patient Health Questionnaire-9	The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.	Baseline and Week 16
Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)	GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calcualed in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.	Baseline and Week 16

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Society for Metabolic and Bariatric Surgery
• Investigators: Principal Investigator: Caitlin E Smith, PhD, Yale University

Publications and helpful links

General Publications

• Chow A, Neville A, Kolozsvari N. Smoking in bariatric surgery: a systematic review. Surg Endosc. 2021 Jun;35(6):3047-3066. doi: 10.1007/s00464-020-07669-3. Epub 2020 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): November 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Health Behavior; Obesity; Smoking Cessation; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Heterocyclic Compounds, 4 or More Rings; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Naltrexone; Cognitive Behavioral Therapy
• Other Study ID Numbers: 2000041069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No