pharmacological and behavioral treatments after bariatric surgery: maintenance treatment (stage 2a)

Conditions: Loss-of-Control Eating; Obesity/Overweight

Summary: this study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. this is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.


Eligibility criteria:
inclusion criteria: * be in the age range ≥18 years of age and ≤70 years of age. * have had laparoscopic roux-en-y gastric bypass or sleeve gastrectomy * approximately ten months post-surgery * experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment responders to a four-month treatment trial of medication and/or bwl * be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies). * read, comprehend, and write english at a sufficient level to complete study-related materials. * provide a signed and dated written informed consent prior to study participation. * be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up). 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 a contraindication to nb medication (e.g., maoi, opiates). * is currently using other medications for weight loss. * has a history of allergy or sensitivity to bupropion or naltrexone. * 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 hypertension. * has current uncontrolled type i or type ii diabetes mellitus. * has untreated hypothyroidism with a tsh \> 1.5 times the upper limit of normal for the - test laboratory with repeat value that also exceeds this limit. * has gallbladder disease. * has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder. * has a recent history of drug or alcohol dependence (since having bariatric surgery). * is currently in active treatment for eating or weight loss. * is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. * is breast-feeding or is pregnant or is not using a reliable form of birth control. * reports active suicidal or homicidal ideation.