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

Launched by YALE UNIVERSITY · Oct 21, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the best ways to treat loss-of-control eating and help with weight management in adults who have recently undergone bariatric surgery, specifically laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. The study will compare two approaches: behavioral treatments that focus on lifestyle changes and a combination of these treatments with medications called naltrexone and bupropion. Researchers want to find out which method, or combination of methods, works best for helping participants feel more in control of their eating and to maintain a healthy weight after surgery.

To be eligible for this study, participants must be between 18 and 70 years old, have a body mass index (BMI) of 30 or higher, and be at least six months post-surgery. They should also experience regular loss-of-control eating. Participants will need to commit to the study for up to 19 months, which includes 7 months of treatment and 12 months of follow-up. It's important for potential participants to know that there are some health conditions and medications that could exclude them from the study, so a thorough medical evaluation will be conducted. This trial is currently recruiting, and those who participate will help advance our understanding of effective treatments for eating and weight management after bariatric surgery.

Gender

ALL

Eligibility 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.