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

Yale University

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Naltrexone and Bupropion medication; Behavioral: Behavioral Weight Loss; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04599478

2000029057

R01DK126637-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Weight Loss

Drug: Naltrexone and Bupropion medication

BWL + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Behavioral: Behavioral Weight Loss

NB medication

Experimental group

Description:

Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.

Treatment:

Drug: Naltrexone and Bupropion medication

Placebo

Placebo Comparator group

Description:

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Treatment:

Other: Placebo