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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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