What is the mechanism of action of this treatment?

Cognitive-behavioral therapy (CBT) and pharmacological treatments like naltrexone are common treatments for eating disorders. CBT focuses on changing dysfunctional beliefs and behaviors related to body image and eating habits, helping patients develop healthier patterns. Naltrexone, an opioid receptor antagonist, reduces the rewarding effects of eating, thereby decreasing binge-eating episodes. Understanding these mechanisms is important for patients to select the most suitable treatment based on their individual symptoms and needs.

What side effects are associated with this type of intervention?

Naltrexone, an opioid receptor antagonist, is being studied for its effectiveness in treating eating disorders such as anorexia nervosa and bulimia nervosa. Common side effects of naltrexone include nausea, headache, dizziness, and fatigue. Other treatments for eating disorders may include antidepressants, which can cause side effects like dry mouth, constipation, and insomnia, and antipsychotics, which may lead to weight gain and metabolic changes. It is important to discuss potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of eating disorders, though specific approvals for opioid receptor antagonists like naltrexone are not highlighted in the provided context. For binge eating disorder, selective serotonin reuptake inhibitors (SSRIs) have shown efficacy and are commonly used. Pharmacotherapy options such as antidepressants and antiepileptics have also been effective in reducing binge eating episodes. While naltrexone is being studied for its potential benefits in pediatric and adolescent eating disorders, its FDA approval status for this specific use is not detailed in the context.

What other types of research exist?

Promising novel alternatives to Naltrexone for eating disorders include hormone replacement therapy for anorexic patients with amenorrhoea, prokinetic agents like cisapride or domperidone to assist in the refeeding process, and glucagon-like peptide 1 receptor agonists, which have shown potential in reducing food intake in binge eating models.

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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)

Must not have

Need for treatment with opioid painkillers

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after enrollment for patients age 16 or younger

Summary

This trial is testing if naltrexone, a medication taken by mouth, can help children and teenagers with anorexia nervosa and bulimia nervosa. The medication works by blocking certain brain signals related to eating disorder behaviors. Participants will receive either naltrexone or another treatment while continuing their regular care. Naltrexone has been used in various psychiatric conditions, including eating disorders, with variable responses in adults and limited data in children.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an eating disorder that involves bingeing or purging.

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I am between 13 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need opioid painkillers for my condition.

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I am at high risk of suicide according to the C-SSRS or ASQ.

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I cannot swallow pills.

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I weigh less than 25kg.

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I have a known genetic or neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at the following timepoints: 6 months after enrollment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ED-15 score

Secondary study objectives

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 study objectives

Genes, Transgenic, Suicide

Columbia Suicide Severity Rating Scale (CSSRS)

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive-behavioral therapy (CBT) and pharmacological treatments like naltrexone are common treatments for eating disorders. CBT focuses on changing dysfunctional beliefs and behaviors related to body image and eating habits, helping patients develop healthier patterns. Naltrexone, an opioid receptor antagonist, reduces the rewarding effects of eating, thereby decreasing binge-eating episodes. Understanding these mechanisms is important for patients to select the most suitable treatment based on their individual symptoms and needs.

Psychotherapy outcome research with bulimia nervosa.Are we overdosing treatment? Secondary findings from a study following women with bulimia nervosa after inpatient treatment.Meta-analysis of the efficacy of psychological and medical treatments for binge-eating disorder.