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Oral Naltrexone In Pediatric Eating Disorders

NCT05073679 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-08-19

Study results available
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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

Interventions

DRUG

Naltrexone Hydrochloride

25mg x 3 days then 50mg a day thereafter

OTHER

Control

Methylcellulose and gelatin capsule only

Sponsors & Collaborators

  • Children's Miracle Network

    collaborator OTHER

  • Rosemary Claire Roden

    lead OTHER

Principal Investigators

  • Rosemary C Roden, MD · PennState Health Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2024-05-21
Completion
2024-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073679 on ClinicalTrials.gov