Overview
This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.
Description
Participants who provide informed consent and are determined to be eligible will then participate in the study.
A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type.
Eligibility
Inclusion Criteria:
- Be in the age range ≥18 years of age and ≤70 years of age.
- Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- Approximately six months post-surgery
- Experience regular loss-of-control eating (defined as at least once weekly over the past 28 days)
- 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 19 months (7-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.