title: A placebo-controlled pilot study of the novel opioid receptor antagonist ALKS-33 in binge eating disorder.
abstract: OBJECTIVE
  To assess preliminarily the effectiveness of a novel opioid antagonist, ALKS-33, in binge eating disorder (BED).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Lindner Center of HOPE, Research Institute, Mason, OH 45040, USA. susan.mcelroy@lindnercenter.org
authors: Susan L
authors: SL
authors: McElroy
authors: Anna I
authors: AI
authors: Guerdjikova
authors: Thomas J
authors: TJ
authors: Blom
authors: Scott J
authors: SJ
authors: Crow
authors: Asli
authors: A
authors: Memisoglu
authors: Bernard L
authors: BL
authors: Silverman
authors: Elliot W
authors: EW
authors: Ehrich
mesh_terms: D000328:Adult; D056912:Binge-Eating Disorder / Q000188:drug therapy*; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009019:Morphinans / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: C583425:ALKS-33; D009019:Morphinans; D009292:Narcotic Antagonists