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A placebo‐controlled pilot study of the novel opioid receptor antagonist ALKS‐33 in binge eating disorder
Authors:Susan L. McElroy MD  Anna I. Guerdjikova PhD  LISW  Thomas J. Blom MS  Scott J. Crow MD  Asli Memisoglu PhD  Bernard L. Silverman MD  Elliot W. Ehrich MD
Affiliation:1. Lindner Center of HOPE, Research Institute, Mason, Ohio;2. Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio;3. Department of Psychiatry, University of Minnesota Medical School, Minneapolis, Minnesota;4. Alkermes Inc., Cambridge, Massachusetts
Abstract:

Objective:

To assess preliminarily the effectiveness of a novel opioid antagonist, ALKS‐33, in binge eating disorder (BED).

Method:

In this randomized, placebo‐controlled, flexible dose, proof‐of‐concept trial, 62 outpatients with BED and obesity received ALKS‐33 (N = 26) or placebo (N = 36) for 6 weeks. Outcome measures of binge eating, body weight, and eating pathology were assessed.

Results:

A large decrease in binge eating episode frequency was observed following both ALKS‐33 and placebo treatment. There was no significant difference between treatment groups in binge eating episode frequency or any other measure of binge eating, body weight, or eating pathology.

Discussion:

In this preliminary proof‐of‐concept study in BED, ALKS‐33 did not separate from placebo. Although a failed trial cannot be excluded, the finding is consistent with earlier observations in bulimia nervosa with other opioid antagonists and suggests ALKS‐33, at least when administered daily for 6 weeks, may not be efficacious for BED. © 2013 by Wiley Periodicals, Inc. (Int J Eat Disord 2013)
Keywords:binge eating disorder  opioid receptor antagonist
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