Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)

Conditions
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Loss-of-control Eating, Obesity/Overweight

Intervention / Treatment
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* Drug: Naltrexone and Bupropion medication
* Behavioral: Behavioral Weight Loss
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication<br>Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form. | Drug: Naltrexone and Bupropion medication<br>* NB medication will be taken daily in pill form.<br>* Other names: Contrave;Behavioral: Behavioral Weight Loss<br>* Behavioral Weight Loss (BWL) counseling includes weekly sessions.<br>|
| Experimental: BWL + Placebo<br>Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form. | Behavioral: Behavioral Weight Loss<br>* Behavioral Weight Loss (BWL) counseling includes weekly sessions.<br>Other: Placebo<br>* Placebo will be inactive and taken daily in pill form.<br>|
| Experimental: NB medication<br>Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form. | Drug: Naltrexone and Bupropion medication<br>* NB medication will be taken daily in pill form.<br>* Other names: Contrave;|
| Placebo Comparator: Placebo<br>Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. | Other: Placebo<br>* Placebo will be inactive and taken daily in pill form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss-of-control Eating Frequency | Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month. | Post-treatment (4 months) | 
| Body Mass Index | BMI is calculated using measured height and weight | Post-treatment (4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss-of-control Eating Remission | Categorical: zero episodes/28 days | Post-treatment (4 months) | 
| Weight loss | Categorical: 5% weight loss | Post-treatment (4 months) | 
| Eating Disorder Psychopathology | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). | Post-treatment (4 months) | 
| Depressive Symptoms | Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms). | Post-treatment (4 months) |