# Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

> **NIH NIH R01** · YALE UNIVERSITY · 2021 · $683,698

## Abstract

Project Summary/Abstract
 Binge eating disorder (BED), a formal DSM-5 diagnosis, is a prevalent, refractory, and serious health
problem experienced by men and women and with heightened psychiatric and medical comorbidity. Although
BED is associated strongly with obesity, BED is distributed across weight categories. Nearly all treatment trials
for BED have required the presence of co-morbid obesity despite epidemiological estimates that 58% of those
with BED are not obese. Current pharmacological treatment options are limited and the sole FDA-approved
medication for BED has a “Limitation of Use” for weight loss and treating obesity. Ideally, an optimal
pharmacological approach for BED would reduce binge eating in those with and without obesity, and have the
added benefit of reducing weight in those with co-morbid obesity.
 The combined use of naltrexone HCI and bupropion HCI (NB) was developed to target alterations in the
hypothalamic melanocortin system and the brain reward system, with the two compounds hypothesized to
work synergistically to reduce food intake. Although NB targets systems highly relevant for those with BED, its
efficacy for reducing binge eating is unknown. Our pilot data shows that NB reduces rates of binge eating
behavior as well as reduces weight in those with co-morbid BED+obesity. The primary aim is to conduct a
double-blind, placebo-controlled parallel group RCT to evaluate the efficacy of NB versus placebo to reduce
binge eating in patients with BED, stratified by obesity status (n=50 per cell, n=200 total) for a 12-week
treatment period and a 12-month follow-up period. The second primary aim evaluates mechanisms underlying
the effect of NB on binge eating. An established human laboratory paradigm will be used to assess eating
behaviors including the ability to resist eating preferred high-caloric food and subsequent over-eating. Potential
mechanisms involved in both homeostatic and hedonic aspects of eating will be examined. We hypothesize
that potential medication-related changes in eating behavior, eating peptides and food craving assessed in the
laboratory will mediate clinical outcomes during the 12-week RCT (i.e., rates of binge eating). The third, and
exploratory aim, assesses eating and drinking behavior, food craving, and mood `in the field' during the first 6
weeks of NB treatment in a subset of participants (n=60) with the use of an innovative biosensor system. We
will examine whether medication-related changes in naturalistic eating behavior relate to clinical outcomes (i.e.,
rates of binge eating).
 This innovative interdisciplinary study will: (1) Provide the first test of the therapeutic potential and related
mechanisms of NB for BED in patients with obesity and without obesity. (2) Identify correlates and potential
mechanisms underlying the effect of NB on binge eating. Evaluating outcomes with innovative human
laboratory and with novel field assessments using wearable biosensors will optimize internal an...

## Key facts

- **NIH application ID:** 10200788
- **Project number:** 5R01DK112771-05
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** CARLOS M GRILO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $683,698
- **Award type:** 5
- **Project period:** 2017-09-25 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200788

## Citation

> US National Institutes of Health, RePORTER application 10200788, Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder (5R01DK112771-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10200788. Licensed CC0.

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