What is naltrexone studying for eating disorders?

Naltrexone is being studied to see how it affects the brain's reward system in adolescents with eating disorders involving binge eating and purging. Researchers want to use brain scans to detect how the drug modulates reward pathways. This trial is led by Children's Mercy Hospital Kansas City to improve understanding of drug effects in this group.

Who may be eligible for this eating disorders clinical trial?

Teens and young adults aged 13 to 21 years with an eating disorder involving binge eating and/or purging may be eligible. Participants must have a stable medication regimen and be able to provide consent or assent. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this eating disorders clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Early Phase 1

Age: 13Years - 21Years

All Genders

ID05509257

Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents With Eating Disorders

Led by Children's Mercy Hospital Kansas City · Updated on 2025-11-25

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating functional magnetic resonance imaging (fMRI) as a biomarker to measure how the brain's reward system responds to the opioid antagonist naltrexone in adolescents and young adults aged 13 to 21 with eating disorders that involve binge eating and/or purging. This early phase 1 trial aims to develop an objective tool to detect acute drug response by measuring changes in specific brain regions related to reward. The study uses a randomized, placebo-controlled, double-blind, crossover design to assess within-individual changes in opioid reward pathway modulation.

CONDITIONS

Brief Title

Naltrexone Neuroimaging in Teens With Eating Disorders

Who Can Participate

Age: 13Years - 21Years

All Genders

Eligibility Criteria

You may qualify if you...

Adolescents and young adults aged 13 to 21 years
Diagnosis of an eating disorder with binge eating and/or purging using DSM-V criteria
Stable medication regimen with no changes in the past 4 weeks
Ability and willingness to provide informed consent or assent (with parent/legal guardian consent if under 18)

You will not qualify if you...

Pregnant individuals (confirmed by urine pregnancy test)
Prior severe allergic reaction to naltrexone, such as anaphylaxis
Presence of non-removable metal in the body incompatible with MRI
Current use of naltrexone
Opioid use within the past 7 days
Language barrier preventing communication or completion of study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 month including both treatment visits and washout period

Participants receive a single oral dose of naltrexone or placebo, followed by a neuroimaging session. After a washout period of at least 2 weeks, participants receive the alternate medication with a second neuroimaging session. Blood samples are collected for up to 7 hours after each medication dose.

2 visits (in-person), each including medication administration and neuroimaging

Trial Site Locations

Total: 1 location

Children's Mercy Research Institute

Kansas City, Missouri, United States, 64108

Actively Recruiting

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Research Team

Mariah L Brewe, BA

Stephani Stancil, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

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