Overview

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.