Oral Naltrexone In Pediatric Eating Disorders

Summary

The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.

Timeline

Start

2022-04-22

Primary completion

2024-05-21

Completion

2024-05-21

Outcome

Outcome not reported

Stopped (Enrollment): “Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder”

Publications

• Background Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26.
• Background Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
• Background Smucker MR, Craighead WE, Craighead LW, Green BJ. Normative and reliability data for the Children's Depression Inventory. J Abnorm Child Psychol. 1986 Mar;14(1):25-39. doi: 10.1007/BF00917219.
• Background Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
• Background Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
• Background Campbell K, Peebles R. Eating disorders in children and adolescents: state of the art review. Pediatrics. 2014 Sep;134(3):582-92. doi: 10.1542/peds.2014-0194.
• Roden RC, Billman M, Lane-Loney S, Essayli J, Mahr F, Vrana K, Ryan S. An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. Contemp Clin Trials. 2022 Nov;122:106937. doi: 10.1016/j.cct.2022.106937. Epub 2022 Sep 24.

Drugs

Indications