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NCT05509257 · ClinicalTrials.gov registry record · Early Phase 1

Naltrexone Neuroimaging in Teens With Eating Disorders

A Early Phase 1 study of Eating Disorders and Bulimia Nervosa, sponsored by Children's Mercy Hospital Kansas City.

Recruiting
Registry status
Early Phase 1
Development phase
60
Enrollment target
1
Study location

NCT05509257: Recruiting Early Phase 1 study of Eating Disorders and Bulimia Nervosa, sponsored by Children's Mercy Hospital Kansas City.

NCT05509257 is a Early Phase 1 study of Eating Disorders and Bulimia Nervosa that is actively recruiting participants, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 60 participants, below the 321-participant average among 37 other Eating Disorders trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05509257, a Early Phase 1 study of Eating Disorders and Bulimia Nervosa, is actively recruiting participants, sponsored by Children's Mercy Hospital Kansas City.

RECRUITING
Registry status
Early Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

Primary Outcome

Acute %Blood oxygenation level dependent (BOLD) change placebo vs. naltrexone in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex)

Interventions

  • DRUG Placebo
  • DRUG Naltrexone

Study Locations (1)

Missouri

  • Children's Mercy Research Institute - Kansas City

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-09-17
Est. Completion 2027-06
Phase Early Phase 1

What NCT05509257 shows while recruiting

NCT05509257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 321-participant average among 37 other Eating Disorders trials with a reported enrollment target (81% lower).

The record links to 5 conditions, with Eating Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05509257 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT05509257 about?

NCT05509257 is a clinical study titled "Naltrexone Neuroimaging in Teens With Eating Disorders". Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation ...

What is the current status of trial NCT05509257?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2022-09-17. Estimated completion is 2027-06.

What conditions does trial NCT05509257 study?

This clinical trial studies the following conditions: Eating Disorders, Bulimia Nervosa, Binge Eating, Purging (Eating Disorders), Anorexia Nervosa, Atypical.

What interventions are being tested in trial NCT05509257?

The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).

Who is sponsoring clinical trial NCT05509257?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05509257 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Eating Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05509257's enrollment target sits among peer trials

60 22nd of 37 higher than 13 of 37 other Eating Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Eating Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05509257, the US trial registry maintained by the National Library of Medicine. NCT05509257 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.