An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders.

Background: This double-blind, placebo-controlled study evaluates the effectiveness of oral naltrexone in adolescents and young adults with eating disorders (EDs) characterized by purging with or without binge-eating behaviors. We hypothesize that participants receiving oral naltrexone will demonstrate greater improvements in body mass index in underweight participants and self-reported ED symptomatology compared to placebo.
Methods: Thirty individuals receiving treatment in a partial hospitalization program for EDs with diagnoses of anorexia nervosa binge-eating/purging type, bulimia nervosa, or purging disorder will receive six weeks of either placebo or oral naltrexone. Participants will complete a battery of self-report measures and laboratory safety monitoring every three weeks in addition to standard of medical care for treatment environment.
Results: Analysis will compare outcomes at weeks three and six, and follow-up at nine weeks and six-months across the oral naltrexone and placebo groups. Main effects for time will examine improvements over the course of treatment for all participants, while group × time interactions will examine differences in the rate of change over time between study arms.
Conclusions: We hypothesize that participants receiving oral naltrexone will experience more rapid improvements in symptom severity and weight restoration compared to placebo across study time points. There are very few medications with high-quality data demonstrating both safety and efficacy in the treatment of eating disorders. The authors theorize this study will demonstrate a clinically significant effect of oral naltrexone on impulsive-type EDs and support its use as an effective option for treatment augmentation.
Competing Interests: Declaration of Competing Interest Dr. Roden is a Nexplanon ® trainer for Organon, Inc., and provides occasional expert witness services for Homestead Medical Experts, LLC. Ms. Billman and Drs Lane-Loney, Essayli, Mahr, Vrana, and Ryan have nothing to disclose.
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