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Brain scans may reveal how naltrexone works in teens with eating disorders

NCT ID NCT05509257

Knowledge-focused Sponsor: Children's Mercy Hospital Kansas City Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether functional MRI (fMRI) brain scans can detect changes caused by a single dose of naltrexone in adolescents aged 13-21 with eating disorders involving binge eating or purging. Participants receive both naltrexone and a placebo in random order, two weeks apart, and undergo brain imaging. The goal is to see if the drug alters activity in reward-related brain regions, which could lead to a new way to measure drug effects in future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Naltrexone
What this could lead to
If successful, this could provide a reliable brain-based test to measure how well opioid-blocking drugs work in eating disorders, potentially guiding future treatments.
What could go wrong
This is a very early, small study (60 participants) focused on measuring brain activity, not treating the disorder. The drug is given only once, so it cannot show long-term effects or real-world benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adolescents and young adults aged 13-21 years * Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria. * Stable medication regimen (no dose or drug changes in the past 4 weeks) * Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study Exclusion Criteria: * Pregnant (via UCG) * Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis) * Non-removable metal in the body that is magnetic resonance imaging incompatible * Current naltrexone use * Self-reported opioid use in the past 7 days * A language barrier (e.g., non-English speaking) for the participant that precludes communication and/or ability to complete all study-related requirements.

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Conditions

The condition(s) this trial relates to.

anorexia nervosa binge eating disorder bulimia nervosa eating disorder Feeding and Eating Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorexia nervosa, atypical Binge eating Bulimia nervosa Eating disorders Purging (eating disorders)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Mercy Research Institute

    RECRUITING

    Kansas City, Missouri, 64108, United States

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