Opening soonPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Smoking Cessation, Bariatric Surgery Patients
Full registry 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.
Treatments and study arms
Naltrexone Hydrochloride
Drug
Participants will be given 50mg/day of Naltrexone for 4 months.
Bupropion HCl Extended Release
Drug
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 Therapy
Behavioral
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.
Primary outcomes
Study enrollment to assess Feasibility16 weeksNumber of participants enrolled out of participants screened
Mean number treatment sessions attended to assess Feasibility16 weeksMean number of treatment sessions attended
Retention to assess Feasibility16 weeksRetention will be measured as the percent of participants that attend the post treatment assessment
Treatment credibility and satisfaction to assess Acceptability16 weeksTreatment 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.
Percent weight changeBaseline and Week 16Percent weight change will be calculated from baseline to post-treatment.
Smoking cessation, as measured by exhaled carbon monoxideBaseline, Week 4, Week 8, Week 12, Week 16Smoking 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 16Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.