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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 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.

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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).

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 the Registry Record Tells You About NCT05509257

The ClinicalTrials.gov registry entry for NCT05509257 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 321-participant average among 37 other Eating Disorders trials with a reported enrollment target (81% lower). The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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