Naltrexone Neuroimaging in Teens With Eating Disorders

This study is looking at how a medication called naltrexone affects the brain's reward system in teenagers and young adults (ages 13-21) with eating disorders that involve binge eating and/or purging. Naltrexone is a drug that blocks the effects of opioids. You would receive a single dose of naltrexone and a single dose of a placebo (an inactive substance) at different times, with a two-week break in between. Researchers will use a special type of brain scan called fMRI (functional magnetic resonance imaging) to see how your brain responds two hours after taking either the naltrexone or the placebo. The goal is to see if fMRI can detect how naltrexone changes activity in specific brain areas related to reward. The study is currently unclear about its recruitment status and plans to enroll 60 participants.

Study design
This is a randomized, placebo-controlled, double-blind, crossover study involving 60 participants. This means you would receive both naltrexone and a placebo at different times, and neither you nor the study staff would know which you are receiving at any given time.
What's involved
You would have two study visits, each involving taking either naltrexone or a placebo, followed by a neuroimaging scan two hours later. There would be a two-week break between these visits.
Compensation
Not stated in the trial record.
Follow-up
Your response will be measured at 2 hours after taking the medication (naltrexone or placebo).

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NCT05509257

Naltrexone Neuroimaging in Teens With Eating Disorders

Recruiting
EARLY_PHASE1Ages 13–21Interventional
Children's Mercy Hospital Kansas City
~60 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:NaltrexonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response
Measured over 2 hours post medication (naltrexone or placebo)
Eating Disorders
Binge Eating
Purging (Eating Disorders)
Bulimia Nervosa
Anorexia Nervosa, Atypical
1 sites across 1 states
Missouri1
  • Stephani Stancil, PhD · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City

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Eligibility criteria

Inclusion

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

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.
  • Response2 hours post medication (naltrexone or placebo)

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