Naltrexone for Eating Disorders

(ONPED Trial)

Overseen By Marley Billman, BS

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Rosemary Claire Roden

Must not be taking: Opioid painkillers

Disqualifiers: Intellectual disability, Genetic disease, Neurologic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of naltrexone, a medication, for young people with eating disorders such as anorexia nervosa and bulimia nervosa. Participants will receive either naltrexone or a placebo (a pill with no active medication) to compare effects. Ideal participants are aged 13-25, already in a treatment program for their eating disorder, and exhibit symptoms like frequent binge eating or purging. The trial aims to determine if naltrexone can help reduce these behaviors. As a Phase 2 trial, this research measures naltrexone's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking opioid painkillers, you cannot participate in the trial.

Is there any evidence suggesting that naltrexone is likely to be safe for humans?

Research shows that naltrexone is generally safe for treating eating disorders. One study found that it can help reduce binge eating and purging, suggesting its safety for this purpose. Although typically used for opioid addiction, naltrexone is FDA-approved, indicating it has passed strict safety tests for that use.

While side effects can occur, they are usually mild. Common ones include nausea and dizziness, which are generally not serious. Prospective trial participants might find this information reassuring regarding the safety of naltrexone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eating disorders?

Unlike the standard treatments for eating disorders, which often revolve around psychological therapy and medications like antidepressants, naltrexone stands out because it targets the brain's opioid receptors. This is a unique approach since these receptors are typically involved in the reward and pleasure systems, which can play a role in the compulsive behaviors seen in eating disorders. Researchers are excited about naltrexone because it might reduce the urge to binge or overeat by altering these reward pathways, potentially offering a new avenue of relief for patients who haven't had success with current therapies.

What evidence suggests that naltrexone might be an effective treatment for eating disorders?

Research has shown that naltrexone, which participants in this trial may receive, can help reduce binge eating and purging in people with eating disorders. Often used to treat addiction, this medication may also manage eating disorders like anorexia nervosa and bulimia nervosa by altering the brain's reward system. It appears to lessen the urge to binge and purge, common issues in these conditions. Although more research is needed, early results suggest that naltrexone could be a promising option for those dealing with eating disorders. ^{1 2 3 4 6}

Who Is on the Research Team?

Rosemary C Roden, MD

Principal Investigator

PennState Health Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My sex does not affect my eligibility.

You have been binge eating and engaging in inappropriate compensatory behaviors at least once a week for the past 3 months.

You have a habit of frequently making yourself vomit or misusing medications to control your weight or body shape.

Exclusion Criteria

Lack of proficiency in written or spoken English

Lactation

I need opioid painkillers for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive oral naltrexone or placebo daily for 6 weeks while attending a partial hospitalization program

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of various indices

6 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Naltrexone Hydrochloride

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Placebo Group 1 Intervention

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

Naltrexone Hydrochloride is already approved in United States, European Union for the following indications:

Approved in United States as ReVia for:

• Alcohol use disorder
• Opioid use disorder

Approved in United States as Vivitrol for:

• Alcohol use disorder
• Opioid use disorder

Approved in United States as Depade for:

• Alcohol use disorder
• Opioid use disorder

Approved in European Union as Naltrexone for:

• Alcohol dependence
• Opioid dependence

Who Is Running the Clinical Trial?

Rosemary Claire Roden

Lead Sponsor

Trials

1

Recruited

10+

Children's Miracle Network

Collaborator

Trials

23

Recruited

1,800+

Published Research Related to This Trial

A systematic review of 49 trials found that only 14% of studies on naltrexone for alcohol dependence had high adherence assurance, which may explain the variability in treatment efficacy observed.

The study revealed a significant correlation between adherence levels and treatment outcomes, suggesting that improving adherence monitoring could enhance the effectiveness of naltrexone in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. Swift, R., Oslin, DW., Alexander, M., et al.[2022]

In a 1-year open-label extension study involving 114 patients, injectable extended-release naltrexone (XR-NTX) demonstrated long-term efficacy, with 50.9% of participants remaining abstinent from opioids throughout the study.

The treatment was generally safe, with only 21.1% of patients reporting adverse events and no severe adverse events noted, although 16.7% experienced elevated liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy]. Krupitsky, EM., Nunes, EV., Ling, W., et al.[2016]

A review of 263 cases related to Vivitrol (extended-release naltrexone) found that 84.6% of fatal overdoses occurred within two months after the last injection, highlighting a critical period for overdose risk.

The study suggests that there may be a link between Vivitrol discontinuation and increased overdose risk, indicating the need for further investigation and monitoring during this time frame.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence. Saucier, R., Wolfe, D., Dasgupta, N.[2019]

A study involving 250 opioid-dependent patients, many of whom had chronic hepatitis C virus (HCV) and HIV, found that intramuscular extended-release naltrexone (XR-NTX) did not significantly increase liver enzyme levels compared to a placebo, indicating its safety in this population.

Even though some patients experienced elevated liver enzymes, these levels improved over time, and no specific symptoms were linked to these elevations, suggesting that XR-NTX can be safely administered to patients with mild to moderate chronic HCV and/or HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. Mitchell, MC., Memisoglu, A., Silverman, BL.[2019]

In a double-blind clinical trial involving 19 out-patient subjects with bulimia nervosa or anorexia nervosa (bulimic subtype), naltrexone significantly reduced binge-purge behaviors compared to placebo.

The study confirmed the effectiveness of naltrexone through rigorous statistical analysis, showing highly significant differences in symptom reduction, supporting its potential as a therapeutic option for these eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone use in the treatment of anorexia nervosa and bulimia nervosa. Marrazzi, MA., Bacon, JP., Kinzie, J., et al.[2019]

This study involves 30 adolescents and young adults with eating disorders, specifically those characterized by purging behaviors, and aims to evaluate the effectiveness of oral naltrexone over six weeks compared to a placebo.

The researchers hypothesize that oral naltrexone will lead to greater improvements in body mass index and self-reported eating disorder symptoms, potentially establishing it as a safe and effective treatment option for impulsive-type eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An experimental protocol for a double-blind placebo-controlled evaluation of the effectiveness of oral naltrexone in management of adolescent eating disorders. Roden, RC., Billman, M., Lane-Loney, S., et al.[2023]

Selective opioid antagonists like naloxone and naltrexone can reduce food intake by up to 30% and change food preferences in short-term studies involving normal-weight, obese, and bulimic individuals.

However, their long-term effectiveness and safety for treating eating disorders such as Prader-Willi syndrome, obesity, bulimia nervosa, or anorexia nervosa are limited, suggesting that the risks may outweigh the benefits, and further research on newer antagonists is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opiate antagonists and eating behavior in humans: a review. de Zwaan, M., Mitchell, JE.[2015]

In a case series of 33 adolescents (average age 15.3 years), naltrexone was found to be safe and well-tolerated, with only 9.1% experiencing nausea, and liver function tests remaining normal for those monitored.

Approximately 67% of the adolescents showed a positive response to naltrexone, indicating reduced purging behaviors, suggesting that it may be an effective treatment option for binge eating and purging in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone Reduces Binge Eating and Purging in Adolescents in an Eating Disorder Program. Stancil, SL., Adelman, W., Dietz, A., et al.[2020]

Citations

1. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002634

An experimental protocol for a double-blind placebo ... This double-blind, placebo-controlled study evaluates the effectiveness of oral naltrexone in adolescents and young adults with eating disorders (EDs)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822572/

Naltrexone Reduces Binge Eating and Purging in ... Objective: Little evidence exists for pharmacologic treatment of binge eating and purging in adolescents with eating disorders. Given the role of the opioid ...

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20220267

Naltrexone-Bupropion and Behavior Therapy, Alone ... One FDA-approved obesity medication, a naltrexone-bupropion combination (22), is a logical treatment to consider for binge-eating disorder ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600891/

Naltrexone/Bupropion for Binge-Eating Disorder Binge-eating disorder (BED) is a prevalent psychiatric disorder associated with obesity. Few evidence-based treatments exist for BED, ...

6. samhsa.gov samhsa.gov/substance-use/treatment/options/naltrexone

What is Naltrexone? Side Effects, Uses, Dose & Risk Intramuscular extended release naltrexone is a medication approved by the Food and Drug Administration (FDA) to treat both opioid use ...