Medicine and Therapy for Weight Loss and Quitting Smoking Before Weight-Loss Surgery

Who can take part

• 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

Who cannot take part

• 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)
• Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates)
• Has taken an investigational drug in another study within 30 days of study consent
• 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
• Requires treatment with opioid-containing medications during the study period
• Has a surgery planned other than bariatric surgery
• Has an acute medical or psychiatric disorder that would make participation difficult or unsafe
• Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute)
• Has a history of anorexia nervosa or history of bulimia nervosa
• 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
• Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment
• 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 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 suicidal or homicidal ideation that requires immediate attention
• Has angle closure glaucoma
• Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent
• Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study
• 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