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TerminatedPhase 2/3

Oral Naltrexone In Pediatric Eating Disorders

Key facts

Who runs it
Rosemary Claire Roden
Where
Hershey, United StatesSee the site
Trial code
Status
Terminated
Phase
Phase 2/3
People taking part
9 people enrolled
Started
22 Apr 2022
Ended
21 May 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Naltrexone Hydrochloride
  • Control
Record updated
19 August 2025
Why it stopped
Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder

Who can take part

Age
13 years to 25 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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:
  • 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
  • Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight
  • Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study; The diagnostic criteria for bulimia nervosa are:
  • Recurrent episodes of binge eating. An episode of binge eating is characterized by
  • both:
  • 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
  • Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise
  • The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months
  • 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

Who cannot take part

  • Need for treatment with opioid painkillers
  • Urine drug screen positive for opioids at enrollment
  • History of known genetic or neurologic disease
  • Positive serum pregnancy test at enrollment
  • 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)
  • Diagnosis of intellectual disability
  • Weight <25kg
  • Inability to swallow pills
  • Lack of proficiency in written or spoken English
  • Lactation

Where in United States

  • Penn State Milton S. Hershey Medical CenterHershey, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • InterventionTreatment being tested

    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

    Treatment: Naltrexone Hydrochloride

  • ControlPlacebo, for comparison

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
Record updated
19 August 2025