Oral Naltrexone In Pediatric Eating Disorders

NCT05073679 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY00014382150408
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa/Bulimia; Anorexia in Adolescence; Anorexia Nervosa, Atypical; Anorexia Nervosa, Binge Eating/Purging Type; Purging (Eating Disorders); Impulsive Behavior; Eating Disorders; Bulimia Nervosa; Eating Disorders in Adolescence

Outcome Measures

Primary Outcomes (6)

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: enrollment

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: one week

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: three week

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: six weeks

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)

• ED-15 Score

  ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology.

  Time Frame: Measured at the following timepoints: 6 months after enrollment

Secondary Outcomes (34)

• Eating Disorder Examination Questionnaire Score (EDE-Q)

  Measured at the following timepoints: enrollment

• Eating Disorder Examination Questionnaire Score (EDE-Q)

  Measured at the following timepoints: one week

• Eating Disorder Examination Questionnaire Score (EDE-Q)

  Measured at the following timepoints: three weeks

• Eating Disorder Examination Questionnaire Score (EDE-Q)

  Measured at the following timepoints: six weeks

• Eating Disorder Examination Questionnaire Score (EDE-Q)

  Measured at the following timepoints: nine weeks (last week of treatment)

Other Outcomes (22)

• Columbia Suicide Severity Rating Scale (CSSRS)

  Measured at enrollment for patients age 17 or older

• Columbia Suicide Severity Rating Scale (CSSRS)

  week 1 for patients age 17 or older

• Columbia Suicide Severity Rating Scale (CSSRS)

  week 2 for patients age 17 or older

Study Arms (2)

Intervention

EXPERIMENTAL

Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler

Drug: Naltrexone Hydrochloride

Control

PLACEBO COMPARATOR

Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks

Other: Control

Interventions

Naltrexone Hydrochloride DRUG

25mg x 3 days then 50mg a day thereafter

Intervention

Control OTHER

Methylcellulose and gelatin capsule only

Control

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 13-25 (inclusive)
• Any sex
• Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria
• Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC
• The diagnostic criteria for anorexia nervosa, binge-purge subtype, are:
• A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected.
• B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight.
• The diagnostic criteria for bulimia nervosa are:
• A. Recurrent episodes of binge eating. An episode of binge eating is characterized by
• B. both:
• i. Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating.
• C. Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise.
• D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months.
• E. Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa.
• The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the absence of binge eating.

You may not qualify if:

• Diagnosis of intellectual disability
• History of known genetic or neurologic disease
• Need for treatment with opioid painkillers
• Weight \<25kg
• Inability to swallow pills
• Lack of proficiency in written or spoken English
• Urine drug screen positive for opioids at enrollment
• Positive serum pregnancy test at enrollment
• Lactation
• Elevation of three times the upper limit of normal for age in either alanine aminotransferase (ALT) or asparagine aminotransferase (AST).High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for participants age 18-25) or Ask Suicide Screening Questions (ASQ, participants age 13 to 17)

Sponsors & Collaborators

• Rosemary Claire Roden: lead
• Children's Miracle Network: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (7)

• 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.

  PMID: 26011054 BACKGROUND

• Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

  PMID: 7866415 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.

  PMID: 3950219 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.

  PMID: 22193671 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.

  PMID: 23027429 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.

  PMID: 25157017 BACKGROUND

• 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.

  PMID: 36167287 DERIVED

Related Links

• Oral naltrexone package insert
• DSM-5 Chapter on Feeding and Eating Disorders

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia; Feeding and Eating Disorders; Impulsive Behavior; Bulimia Nervosa

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Limitations and caveats include low participant sample and participant attrition. No outcome data collected for outcome measures 48, 49, 50, 51, and 59 because participants were lost to follow-up at those time points.

Results Point of Contact

• Title: Dr. Rosemary Claire Roden
• Organization: Penn State College of Medicine

rroden@pennstatehealth.psu.edu

717-531-1383

Study Officials

• Rosemary C Roden, MD

  PennState Health Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Penn State Health IDS pharmacy will purchase Naltrexone 50mg tablets from a pharmaceutical wholesaler. The IDS pharmacy will purchase gelatin capsules and USP grade methylcellulose from a pharmacy supplier to be used for compounding the active and placebo capsules. For the active Naltrexone 50mg capsules, a Naltrexone 50mg tablet will be placed in an empty gelatin capsule with methylcellulose filler. The placebo capsules will be empty gelatin capsules filled with Methylcellulose. Participants will be randomized using redcap at enrollment to either study article or placebo, and neither investigators nor care providers will be aware of which article the participants receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: double-blind, placebo controlled randomized clinical trial

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: October 11, 2021
• Study Start: April 22, 2022
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)