drugset / Trial / NCT03047005
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Phase 2/3
Completed
68 enrolled
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. 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.
Timeline
- Start
- 2017-08-28
- Primary completion
- 2021-12-16
- Completion
- 2022-12-16
Outcome
Mixed primary results
registry analysis (superiority test); NB Medication vs Placebo; p = .07; Mixed Models Analysis NCT03047005 ↗
registry analysis (superiority test); NB Medication vs Placebo; p = .01; Mixed Models Analysis NCT03047005 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 360 mg | Oral |
| Subject | Naltrexone | Small molecule | 32 mg | Oral |