ObesityPhase 1/2NCT07398404
A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
A Phase 1/2 study testing Naltrexone hydrochloride, Bupropion Hydrochloride 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.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Smoking Cessation, Bariatric Surgery Patients
- What is being tested?
- Naltrexone hydrochloride, Bupropion Hydrochloride Extended-release and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2031
- Phase
- Phase 1/2
- 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 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29407
Caitlin E Smith, PhD, 203-785-7210, smithcai@musc.edu
About this study
Official title: 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.
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. 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.
- Conditions
- Obesity, Smoking Cessation, Bariatric Surgery Patients
- Being tested
- Naltrexone hydrochloride, Bupropion Hydrochloride 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 Hydrochloride 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 group | Role | What they receive |
|---|---|---|
| MHBC Intervention Group | Experimental | Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion). Receives: Drug: Naltrexone hydrochloride; Drug: Bupropion Hydrochloride Extended-release; Behavioral: Cognitive-Behavioral Therapy |
| Control Group | No intervention | Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study enrollment to assess Feasibility
Number of participants enrolled out of participants screened.
Measured: 16 weeks
Mean number treatment sessions attended to assess Feasibility
Mean number of treatment sessions attended.
Measured: 16 weeks
Retention to assess Feasibility
Retention will be measured as the percent of participants that attend the post treatment assessment.
Measured: 16 weeks
Treatment credibility to assess Acceptability
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).
Measured: Week 4, Week 8, Week 12, Week 16
Treatment satisfaction to assess Acceptability
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).
Measured: Week 16
Percent weight change
Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
Measured: Baseline, Week 16, 6-month follow-up
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, 6-month follow-up
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, 6-month follow-up
Secondary outcomes (4)
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, Week 16, 6-month follow-up
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, Week 16, 6-month follow-up
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 calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.
Measured: Baseline, Week 16, 6-month follow-up
Number of participants with Bariatric surgery completion
Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the active intervention group or the standard of care control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Caitlin Smith, Medical University of South Carolina
- Investigators
- Caitlin E Smith, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398404
- Sponsor's protocol ID
- 2000041823
- Other IDs
- 1K23DA064898-01
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT07398404
- Acronym / sponsor ID
- 2000041823
- Conditions
- Obesity, Smoking Cessation, Bariatric Surgery Patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the active intervention group or the standard of care control group.
| Arm | Type | Receives |
|---|---|---|
| MHBC Intervention Group | Experimental | Drug: Naltrexone hydrochloride, Drug: Bupropion Hydrochloride Extended-release, Behavioral: Cognitive-Behavioral TherapyParticipants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion). |
| Control Group | No intervention | –Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone hydrochlorideParticipants will be given 50mg/day of Naltrexone for 4 months. | Drug | MHBC Intervention Group |
| Bupropion Hydrochloride Extended-releaseParticipants 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). | Drug | MHBC Intervention Group |
| Cognitive-Behavioral TherapyParticipants 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. | Behavioural | MHBC Intervention Group |
Primary outcome
Study enrollment to assess Feasibility
Time frame: 16 weeks
Number of participants enrolled out of participants screened.
Mean number treatment sessions attended to assess Feasibility
Time frame: 16 weeks
Mean number of treatment sessions attended.
Retention to assess Feasibility
Time frame: 16 weeks
Retention will be measured as the percent of participants that attend the post treatment assessment.
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).
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).
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.
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.
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.
4 secondary outcomes
Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence
Time frame: 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
Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)
Time frame: Baseline, Week 16, 6-month follow-up
Number of participants with Bariatric surgery completion
Time frame: 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 32524412Chow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin E Smith, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Naltrexone hydrochloride, Bupropion Hydrochloride 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 24 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 8 Jul 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 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 NCT07398404, 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 8 Jul 2026.