# Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder

> **NIH NIH R01** · YALE UNIVERSITY · 2020 · $715,835

## Abstract

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and
bio-psychosocial impairment. Improved treatments for patients with BED and obesity are needed that can
produce sustained clinical outcomes.
 This study aims to perform a two-stage randomized controlled trial (RCT) to compare the effectiveness of
two leading but distinct treatments — lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) — alone
and in combination, for BED. LDX is the only FDA-approved medication for BED, has demonstrated short-term
effectiveness relative to placebo, but comparative effectiveness to other active treatments and longer-term
outcomes are unknown. The first stage RCT will provide new findings regarding the relative effectiveness of
LDX, CBT, and combined CBT+LDX for obese patients with BED. The second stage RCT will provide novel
findings from a controlled test, whether amongst Stage 1 patients who received acute pharmacotherapy with
LDX (i.e., LDX or CBT+LDX) and showed a positive clinical response, continued LDX medication results in
superior maintenance and longer-term outcomes than placebo. The second Stage RCT will also provide novel
findings regarding whether amongst non-responders to Stage 1 pharmacotherapy, switching to an alternative
medication (Naltrexone-Bupropion; FDA-approved for obesity) results in clinical improvements. This study
addresses the dearth of research on longer-term outcomes of pharmacotherapy for BED, which is strikingly at
odds with the public health significance of BED, including documented prevalence, strong association with
obesity, and heightened bio-psychosocial morbidity.
 In Stage 1 RCT, N=180 obese patients with BED will be randomly assigned to one of three 12-week
interventions: CBT, LDX, or CBT+LDX. In Stage 2, patients who received acute pharmacotherapy (LDX or
CBT+LDX) and were “responders” (65% or greater reduction in binge eating) will be randomized in equal
proportions (stratified blocked randomization with first treatment as stratifying variable) to LDX or placebo
(double-blind) for 12 weeks. “Non-responders” to acute pharmacotherapy will be randomized to a second
medication (Naltrexone-Bupropion or placebo; double-blind) for 12 weeks. Stage 1 patients receiving CBT will
be followed without further intervening treatment. Independent outcome assessments will determine relative
acute effectiveness, medication maintenance effectiveness, and longer-term maintenance through 18 months.
Secondary aims are to contribute important new data regarding predictors of outcomes and moderators of
treatment effects to inform prescription (i.e., for whom the LDX and CBT work best), exploration of mediators
through which these two distinct methods work, exploration of alternmative pharmacotherapy for initial non-
responders, and generation of cost-effectiveness estimates.
 This study will produce novel findings regarding “adaptive” SMART treatment methods for BED and obesity.

## Key facts

- **NIH application ID:** 9981731
- **Project number:** 5R01DK114075-03
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** CARLOS M GRILO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $715,835
- **Award type:** 5
- **Project period:** 2018-08-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9981731

## Citation

> US National Institutes of Health, RePORTER application 9981731, Cognitive-Behavioral and Pharmacologic Treatment of Binge Eating Disorder (5R01DK114075-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9981731. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*