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Weight Loss and Smoking Cessation for Bariatric Surgery Patients

This study is testing a new approach for people considering weight-loss surgery (bariatric surgery) who also smoke. It combines two medications, Naltrexone hydrochloride and Bupropion Hydrochloride Extended-release, with weekly counseling (cognitive-behavioral therapy) to help with both weight loss and quitting smoking. You might be able to join if you are 18-65 years old, actively thinking about bariatric surgery, smoke at least 5 cigarettes daily, and have a BMI of 30 or higher. The main goal is to see if this combined approach is practical and acceptable, and how many people attend sessions and stay in the study over 16 weeks. The study status is currently unclear.

Study design
This is a pilot randomized control trial aiming to enroll 64 participants. It compares the intervention to a standard of care control group.
What's involved
Participants will take Naltrexone and Bupropion daily for 4 months. They will also meet with a study clinician weekly for 60 minutes for 4 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at 16 weeks, which is the duration of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07398404

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

Not Yet Recruiting
PHASE1Ages 18–65InterventionalTreatment
Medical University of South Carolina
~64 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Naltrexone hydrochlorideBupropion Hydrochloride Extended-releaseCognitive-Behavioral Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study enrollment to assess Feasibility
Measured over 16 weeks
+7 more outcomes measured

Conditions

Obesity
Smoking Cessation
Bariatric Surgery Patients

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Caitlin E Smith, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Caitlin E Smith, PhD
[email protected]
203-785-7210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Study enrollment to assess Feasibility16 weeks

    Number of participants enrolled out of participants screened.

  • Mean number treatment sessions attended to assess Feasibility16 weeks

    Mean number of treatment sessions attended.

  • Retention to assess Feasibility16 weeks

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

  • Treatment credibility to assess AcceptabilityWeek 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).

  • Treatment satisfaction to assess AcceptabilityWeek 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).

  • Percent weight changeBaseline, 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.

  • Smoking cessation, as measured by exhaled carbon monoxideBaseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up

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

  • Smoking cessation, as measured by timeline followback interviewBaseline, 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.