Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study will develop and test a program to help adults lose weight and quit smoking before weight-loss surgery. The program uses two medicines, naltrexone and bupropion, plus therapy to help change habits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–65 years old and actively thinking about weight-loss surgery.
- Have smoked at least 5 cigarettes a day for the past 3 months.
- Have a body mass index (BMI) of 30 or higher. BMI is a measure of weight compared with height.
- Not take medicines that cannot safely be used with naltrexone or bupropion, such as opioid pain medicines or benzodiazepines.
- Have no past health problems that make these study medicines unsafe, such as seizures, uncontrolled high blood pressure, heart problems, stroke, or certain eating disorders.
- Be well enough to take part, including being able to walk on your own, and be able to speak, read, and write English.
- Not be pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
- Have no current thoughts of suicide or killing someone else.
Who can't join
- Have a higher risk of seizures because of your health history, family history, or treatments. This includes past seizures, childhood seizures with fever, a brain tumor, brain blood vessel disease, or a serious head injury.
- Have ever had anorexia or bulimia, which are eating disorders.
- Take medicines that cannot safely be used with the study drugs, such as MAOI medicines or opioids, or have an allergy or sensitivity to either study drug.
- Have a mental health condition needing hospital care or more intensive treatment, or current thoughts of suicide or killing someone else.
- Have untreated high blood pressure with a seated top number above 160 or bottom number above 100, or a heart rate above 100 beats per minute.
- Have a history of heart or blood vessel disease, heart defects present at birth, an uneven heartbeat needing medicine, or brain blood vessel problems, including stroke.
- Have uncontrolled type 1 or type 2 diabetes; a history of severe kidney, liver, nerve, long-term lung, or gallbladder disease; or another unstable medical condition.
- Be pregnant, breastfeeding, or not using reliable birth control.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
Study sites (1)
SC
- Medical University of South Carolina · Charleston, SC 29407Caitlin E Smith, PhD · Study contact · 203-785-7210 · smithcai@musc.eduMore trials in Charleston