A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

March 17, 2026 updated by: Yale University

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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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. This study aims to evaluate 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 randomized control trial will evaluate feasibility and acceptability of the intervention and compare the intervention to a standard of care control group.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be 18-65 years old.
  • 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.
  • 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 an acute medical or psychiatric disorder that would make participation difficult or unsafe.
  • Has suicidal or homicidal ideation that requires immediate attention.
  • 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 evidence of a second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram that would preclude safe participation.
  • Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute).
  • Has elevated bilirubin test or any other liver function test value > 5 times the upper limit of normal laboratory criteria.
  • Has a platelet count < 100x10 3/uL.
  • 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 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, including cancer.
  • Has angle closure glaucoma.
  • Has taken an investigational drug in another study within 30 days of study consent.
  • Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.
  • Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.
  • Is receiving ongoing treatment with tricyclic antidepressants, xanthines, systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous stimulants, or any medication that could interact adversely with the study medications.
  • Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.
  • Requires treatment with opioid-containing medications during the study period.
  • Has a surgery planned other than bariatric surgery.
  • Is currently in jail, prison, or any inpatient overnight facility as required by a court of law or have pending legal action or other legal situation that could prevent participation.
  • Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MHBC Intervention Group
Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
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.
Drug: Naltrexone hydrochloride
Participants will be given 50mg/day of Naltrexone for 4 months.
Drug: Bupropion Hydrochloride 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).
No Intervention: Control Group
Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study enrollment to assess Feasibility
Time Frame: 16 weeks
Number of participants enrolled out of participants screened.
16 weeks
Mean number treatment sessions attended to assess Feasibility
Time Frame: 16 weeks
Mean number of treatment sessions attended.
16 weeks
Retention to assess Feasibility
Time Frame: 16 weeks
Retention will be measured as the percent of participants that attend the post treatment assessment.
16 weeks
Treatment credibility to assess Acceptability
Time Frame: Week 4, Week 8, Week 12, Week 16
Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility).
Week 4, Week 8, Week 12, Week 16
Treatment satisfaction to assess Acceptability
Time Frame: Week 16
Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction).
Week 16
Percent weight change
Time Frame: Baseline, Week 16, 6-month follow-up
Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
Baseline, Week 16, 6-month follow-up
Smoking cessation, as measured by exhaled carbon monoxide
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
Smoking cessation, as measured by timeline followback interview
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
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, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence
Time Frame: Baseline, Week 16, 6-month follow-up
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, Week 16, 6-month follow-up
Depressive symptomatology, as measured by the Patient Health Questionnaire-9
Time Frame: Baseline, Week 16, 6-month follow-up
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, Week 16, 6-month follow-up
Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)
Time Frame: Baseline, Week 16, 6-month follow-up
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 calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.
Baseline, Week 16, 6-month follow-up
Number of participants with Bariatric surgery completion
Time Frame: 6-month follow-up
Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Caitlin E Smith, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000041823
  • 1K23DA064898-01 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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