Phase 3
N=89
Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Binge-Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03539900 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Binge Eating Frequency — 6.4; 5.4 binge-eating episodes per month — p=.44
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Binge Eating Frequency |
6.36; 5.33 | .44 |
| PRIMARY Percent BMI Change |
-8.0; -0.5 | .04 sig |
| SECONDARY Change in Binge Eating Frequency |
6.36; 5.33 | .44 |
| SECONDARY Change in Binge Eating Frequency |
6.36; 5.33 | .44 |
| SECONDARY Body Mass Index |
-0.20; 3.43 | .40 |
| SECONDARY Body Mass Index |
-0.20; 3.43 | .40 |
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.
Eligibility Criteria
Inclusion Criteria
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
- BMI in the obesity (BMI >30 and 21.5 and <29.9) range;
- Available for the duration of the treatment and follow-up (15 months);
- Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion Criteria
- Currently taking opioid pain medications or drugs; or positive drug screen for opiates
- Currently taking medications that influence eating/weight;
- History of seizures;
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
- Past or current anorexia nervosa or bulimia nervosa;
- Pregnant or breastfeeding;
- Medical status judged by study physician as contraindication.
Data sourced from ClinicalTrials.gov (NCT03539900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.