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

• Status: Recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Bupropion; Naltrexone

Criteria

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.