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Int J Eat Disord. 2013 Apr;46(3):239-45. doi: 10.1002/eat.22114. Epub 2013 Feb 5.

A placebo-controlled pilot study of the novel opioid receptor antagonist ALKS-33 in binge eating disorder.

Author information

1
Lindner Center of HOPE, Research Institute, Mason, OH 45040, USA. susan.mcelroy@lindnercenter.org

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01098435.

PMID:
23381803
DOI:
10.1002/eat.22114
[Indexed for MEDLINE]
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