Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes after Bariatric Surgery
- Study HIC#:2000029057
- Last Updated:08/20/2021
Concerns about your eating or weight after bariatric surgery?
If you are 18 to 70 years old and concerned about your weight or eating after bariatric surgery, you may be eligible to participate in a free and confidential treatment study. Participants will receive up to $50 - $375 compensation.
To learn more or see if you are eligible to participate, please call the Yale Program for Obesity, Weight, and Eating Research at (203) 785-7210 or visit power.yale.edu
- Start Date06/29/2021
- End Date11/30/2027
- 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).
- 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.