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ObesityPhase 1NCT07224087

Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

A Phase 1 study testing Naltrexone Hydrochloride, Bupropion HCl Extended Release and Cognitive-Behavioral Therapy in people with Obesity and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Naltrexone Hydrochloride, Bupropion HCl Extended Release and Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caitlin E Smith, PhD contact

203-785-7210

smithcai@musc.edu

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29407

    Caitlin E Smith, PhD, 203-785-7210, smithcai@musc.edu

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Naltrexone Hydrochloride, Bupropion HCl Extended Release, Cognitive-Behavioral Therapy
Medical subject headings
Obesity, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naltrexone HydrochlorideDrug

    Participants will be given 50mg/day of Naltrexone for 4 months.

  • Bupropion HCl Extended ReleaseDrug

    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).

  • Cognitive-Behavioral TherapyBehavioural

    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.

Study groups in NCT07224087
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Drug: Naltrexone Hydrochloride; Drug: Bupropion HCl Extended Release; Behavioral: Cognitive-Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study enrollment to assess Feasibility

    Number of participants enrolled out of participants screened

    Measured: 16 weeks

  2. Mean number treatment sessions attended to assess Feasibility

    Mean number of treatment sessions attended

    Measured: 16 weeks

  3. Retention to assess Feasibility

    Retention will be measured as the percent of participants that attend the post treatment assessment

    Measured: 16 weeks

  4. 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.

    Measured: 16 weeks

  5. Percent weight change

    Percent weight change will be calculated from baseline to post-treatment.

    Measured: Baseline and Week 16

  6. Smoking cessation, as measured by exhaled carbon monoxide

    Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16

  7. Smoking cessation, as measured by timeline followback interview

    Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 16

Secondary outcomes (3)

  1. 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.

    Measured: Baseline and Week 16

  2. 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.

    Measured: Baseline and Week 16

  3. 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.

    Measured: Baseline and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive the intervention.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224087
Sponsor's protocol ID
Pro00152089
Status last verified
Sep 2026
First submitted
23 Oct 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32524412

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Naltrexone Hydrochloride, Bupropion HCl Extended Release and Cognitive-Behavioral Therapy in people with Obesity and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caitlin E Smith, PhD (203-785-7210, smithcai@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study enrollment to assess Feasibility (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224087, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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