Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)

Launched by YALE UNIVERSITY · Oct 21, 2020

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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.