drugset / Trial / NCT03539900
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Phase 2/3
Completed
89 enrolled
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
Timeline
- Start
- 2018-04-17
- Primary completion
- 2022-04-19
- Completion
- 2023-03-22
Outcome
Mixed primary results
registry analysis (superiority test); NB Medication vs Placebo; p = .44; Mixed Models Analysis NCT03539900 ↗
registry analysis (superiority test); NB Medication vs Placebo; p = .04; Mixed Models Analysis NCT03539900 ↗
registry MEAN NB Medication: -8.0 (Standard Deviation 11.3) percent BMI change MEAN Placebo: -0.5 (Standard Deviation 8.9) percent BMI change NCT03539900 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 360 mg | Oral |
| Subject | Naltrexone | Small molecule | 32 mg | Oral |