Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Overview
- Phase
- Phase 2
- Intervention
- Naltrexone and Bupropion (NB) medication
- Conditions
- Loss-of-Control Eating
- Sponsor
- Yale University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Loss-of-control eating Relapse
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be in the age range ≥18 years of age and ≤70 years of age.
- •Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- •Approximately ten months post-surgery
- •Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment responders to a four-month treatment trial of medication and/or BWL
- •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 15 months (3-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.
Arms & Interventions
Naltrexone+Bupropion Medication
Intervention: Naltrexone and Bupropion (NB) medication
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Loss-of-control eating Relapse
Time Frame: From post-treatment to the 12-month follow-up
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Body Mass Index (BMI)
Time Frame: From post-treatment to the 12-month follow-up
BMI is calculated using measured height and weight
Loss-of-control eating Relapse
Time Frame: From baseline interview at study enrollment to after the 12-week treatment
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Loss-of-control eating Relapse
Time Frame: From post-treatment to the 6-month follow-up
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
Body Mass Index (BMI)
Time Frame: From baseline at study enrollment to after the 12-week treatment
BMI is calculated using measured height and weight
Body Mass Index (BMI)
Time Frame: From post-treatment to the 6-month follow-up
BMI is calculated using measured height and weight
Secondary Outcomes
- Loss-of-control eating Frequency(From post-treatment to the 12-month follow-up)
- Eating Disorder Psychopathology(From post-treatment to the 12-month follow-up)
- Depressive Symptoms(From post-treatment to the 12-month follow-up)
- Loss-of-control eating Frequency(From baseline interview at study enrollment to after the 12-week treatment)
- Loss-of-control eating Frequency(From post-treatment to the 6-month follow-up)
- Eating Disorder Psychopathology(From baseline interview at study enrollment to after the 12-week treatment)
- Eating Disorder Psychopathology(From post-treatment to the 6-month follow-up)
- Depressive Symptoms(From baseline at study enrollment to after the 12-week treatment)
- Depressive Symptoms(From post-treatment to the 6-month follow-up)