# Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

> **NIH NIH R01** · YALE UNIVERSITY · 2020 · $632,734

## Abstract

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and
bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce
sustained clinical outcomes and promote weight loss. This renewal application builds on previous project.
 This study aims to perform a two-stage RCT to test the effectiveness of behavioral weight loss (BWL)
and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity
combination medication), alone and in combination, for the treatment of BED in obese patients. The first stage
RCT will provide new findings regarding the effectiveness of NB medication and whether this specific
combination of BWL and NB medication is effective for obese patients with BED. The second stage RCT will
provide novel findings from a controlled test, amongst Responders to Stage 1, whether NB medication results
in superior maintenance and lower-term outcomes than placebo. The second stage RCT will also explore using
a controlled test, amongst Non-responders to Stage 1 treatment, whether adding cognitive-behavioral therapy
(CBT) enhances on-going pharmacotherapy (NB/placebo).
 In Stage 1 RCT, N=160 obese patients with BED will be randomly assigned (double-blind) in a
balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or
Placebo. In Stage 2 RCT, “Responders” to Stage 1 treatments (defined as 65% or greater reduction in binge
eating) will be randomized in equal proportions (stratified blocked randomization with Stage 1 treatment as
stratifying variable) to NB or placebo (double-blind) for 16 weeks. “Non-responders” to Stage 1 treatments will
continue on-going pharmacotherapy (NB/placebo; double-blind) with 50% randomized to also receive CBT.
Independent evaluators will perform comprehensive assessments of both binge eating and obesity and their
associated outcomes through 12-month follow-ups (i.e., 20 months after initial randomization).
 This study will produce important new information about the relative efficacy of BWL and this recently
FDA-approved anti-obesity NB medicine), alone and in combination, for BED in obese patients. This study will
produce new and novel information regarding whether amongst Responders to initial acute treatments, NB
medication results in superior maintenance and longer term outcomes than placebo. This study will produce
important findings regarding predictors, moderators, and mediators of outcomes that have implication for
empirically-guided prescription and further refinement of treatments. Finally, this study will produce novel
information regarding whether amongst Non-responders to initial acute treatments, adding CBT enhances on-
going pharmacotherapy outcomes.

## Key facts

- **NIH application ID:** 10000884
- **Project number:** 5R01DK049587-20
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** CARLOS M GRILO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $632,734
- **Award type:** 5
- **Project period:** 1999-07-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10000884

## Citation

> US National Institutes of Health, RePORTER application 10000884, Behavioral and Pharmacologic Treatment of Binge Eating and Obesity (5R01DK049587-20). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10000884. Licensed CC0.

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