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Opioid Antagonist

Naltrexone for Eating Disorders (ONPED Trial)

Phase 2 & 3
Waitlist Available
Led By Rosemary C Roden, MD
Research Sponsored by Rosemary Claire Roden
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Ages 13-25 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after enrollment for patients age 16 or younger
Awards & highlights

ONPED Trial Summary

This trial will compare the effectiveness of naltrexone, a medication used to treat addiction, to placebo in treating adolescent eating disorders.

Who is the study for?
This trial is for young people aged 13-25 with eating disorders like anorexia nervosa or bulimia, who are in a hospital program for treatment. They must be able to swallow pills and understand English. Those underweight (<25kg), using opioids, pregnant, lactating, or at high suicide risk can't join.Check my eligibility
What is being tested?
The study tests if oral naltrexone tablets help treat pediatric and adolescent eating disorders compared to a placebo. Participants are already enrolled in intensive outpatient or partial hospitalization programs for their condition.See study design
What are the potential side effects?
Naltrexone may cause stomach pain, nausea, headache, dizziness, fatigue or trouble sleeping. It's not addictive but could interact with alcohol or opioid medications causing serious effects.

ONPED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with an eating disorder that involves bingeing or purging.
Select...
I am between 13 and 25 years old.

ONPED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at the following timepoints: 6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the following timepoints: 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ED-15 score
Secondary outcome measures
Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS)
Eating Disorder Examination Questionnaire score (EDE-Q)
+4 more
Other outcome measures
Genes, Transgenic, Suicide
Columbia Suicide Severity Rating Scale (CSSRS)

ONPED Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
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
Group II: ControlPlacebo Group1 Intervention
Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone Hydrochloride
2021
Completed Phase 1
~330

Find a Location

Who is running the clinical trial?

Rosemary Claire RodenLead Sponsor
Children's Miracle NetworkOTHER
22 Previous Clinical Trials
1,779 Total Patients Enrolled
Rosemary C Roden, MDPrincipal InvestigatorPennState Health Children's Hospital

Media Library

Naltrexone Hydrochloride (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05073679 — Phase 2 & 3
Eating Disorders Research Study Groups: Intervention, Control
Eating Disorders Clinical Trial 2023: Naltrexone Hydrochloride Highlights & Side Effects. Trial Name: NCT05073679 — Phase 2 & 3
Naltrexone Hydrochloride (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073679 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Naltrexone Hydrochloride typically given to patients?

"While Naltrexone Hydrochloride is commonly used to help patients manage their weight, it can also be useful in reducing pain and promoting increased physical activity and reduced-calorie diets."

Answered by AI

Are investigators actively looking for more participants for this research project?

"No, this specific study is not looking for patients at the moment. Although it was first posted on April 22nd, 2022 and updated last on August 25th, there are 1145 other clinical trials that are currently seeking participants."

Answered by AI

How many individuals are currently participating in this clinical trial?

"As of 8/25/2022, this study is no longer recruiting patients. This clinical trial was posted on 4/22/202 and the last update was on 8/25/2022. If you are looking for other studies, there are 1093 trials actively recruiting participants with bulimia nervosa and 52 trials for Naltrexone Hydrochloride enrolling participants."

Answered by AI

Could I possibly be a candidate for this clinical research?

"This clinical trial is looking for 60 participants that have been diagnosed with bulimia nervosa. The ages of the patients must fall between 13 and 25. To be eligible, candidates must meet the following criteria: a diagnosis 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; intense fear of gaining weight or of becoming fat,"

Answered by AI

Are the subjects of this experiment restricted to those aged 18 and up?

"Patients aged 13 to 25 are eligible for this study, as per the inclusion criteria. In contrast, there are 315 clinical trials available for minors and 740 studies open to seniors."

Answered by AI

What other scientific work has been done on Naltrexone Hydrochloride?

"There are 52 active studies involving Naltrexone Hydrochloride, with the majority of phase 3 trials taking place in New york City. However, there are a total of 175 clinical trial sites for this medication across the United States."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Minnesota
How old are they?
18 - 65
What site did they apply to?
Penn State Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~20 spots leftby May 2025