Weight Regain Treatment Post-Bariatric Surgery

Yale University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Obesity, Overweight

Treatments

Behavioral: Behavioral Weight Loss (BWL)

Behavioral: Early Responder: BWL continued

Combination Product: Early Non-responder: BWL continued with medication added

Study type

Interventional

Funder types

Other

Identifiers

NCT04662801

2000029491

Details and patient eligibility

About

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Enrollment

26 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 kg/m2
Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Experiencing weight regain after bariatric surgery
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 3 months.

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.