A Phase 1 interventional study of Naltrexone Hydrochloride and Bupropion HCl Extended Release in Obesity, Smoking Cessation and Bariatric Surgery Patients, sponsored by Medical University of South Carolina. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Medical University of South Carolina · Phase 1, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 20 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Drug: Naltrexone Hydrochloride · Drug: Bupropion HCl Extended Release · Behavioral: Cognitive-Behavioral Therapy
Participants will be given 50mg/day of Naltrexone for 4 months.
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).
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 enrollment to assess Feasibility
Number of participants enrolled out of participants screened
Time frame: 16 weeks
Mean number treatment sessions attended to assess Feasibility
Mean number of treatment sessions attended
Time frame: 16 weeks
Retention to assess Feasibility
Retention will be measured as the percent of participants that attend the post treatment assessment
Time frame: 16 weeks
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.
Time frame: 16 weeks
Percent weight change
Percent weight change will be calculated from baseline to post-treatment.
Time frame: Baseline and Week 16
Smoking cessation, as measured by exhaled carbon monoxide
Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Smoking cessation, as measured by timeline followback interview
Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
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.
Time frame: Baseline and Week 16
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.
Time frame: Baseline and Week 16
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.
Time frame: Baseline and Week 16
Plan to share: No
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 105 non-industry phase 1 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 14 months is below that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Naltrexone · Bupropion Hydrochloride Controlled-release
Medical University of South Carolina →