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Led by Children's Mercy Hospital Kansas City · Updated on 2025-11-25
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers are evaluating functional magnetic resonance imaging fMRI as a biomarker to measure how the brains reward system responds to the opioid antagonist naltrexone in adolescents and young adults aged 13 to 21 with eating disorders that involve binge eating andor 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
Naltrexone Neuroimaging in Teens With Eating Disorders
M
Mariah L Brewe, BA
S
Stephani Stancil, PhD
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Children's Mercy Hospital Kansas City
Lead Sponsor
University of Kansas Medical Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Naltrexone given before neuroimaging | Placebo given before neuroimaging |
|---|---|---|
| What is it? | A single oral dose of naltrexone administered before neuroimaging, designed to evaluate its acute impact on brain function and physiological markers in adolescents and young adults with eating disorders. | A single oral dose of placebo administered before neuroimaging, used as a control to compare brain and physiological responses against naltrexone in the same participant group. |
| Role in the trial | Evaluates the effect of acute opioid receptor blockade on neurobiological responses related to eating disorders. | Serves as the control condition, allowing researchers to distinguish the specific effects of naltrexone from baseline responses. |
| Primary use or clinical goal | To study the neurobiological and physiological effects of naltrexone during tasks relevant to appetite, reward, and control in adolescents with eating disorders. | Establishes baseline for neuroimaging and behavioral response without active opioid antagonism, enabling assessment of naltrexone's effects. |
| How is it given or performed? | Participants receive a single oral dose of naltrexone 2 hours before undergoing neuroimaging procedures on one of two study visits, assigned in random order. | Participants receive a single oral dose of placebo 2 hours before neuroimaging, with the sequence randomized and sessions separated by two-week washout. |
| Evidence and study status | The effects of naltrexone on neuroimaging and physiological markers in adolescents with eating disorders are being investigated in this ongoing randomized, crossover study. No clinical outcome results are posted yet. | This condition provides a comparison baseline for research purposes. No outcome results distinguishing it from naltrexone are posted as the trial is ongoing. |
| Important limitations | The study evaluates only single-dose effects in a neuroimaging setting and does not assess long-term behavioral or clinical outcomes. The adolescent/young adult population and crossover design may limit direct applicability to broader treatment use. | As the placebo session is used only for within-participant comparison, it does not represent any form of active treatment or standard care. Conclusions regarding real-world benefit require further clinical outcome studies. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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Stephani L Stancil, Mariah E Brewe, John Tumberger...
https://pubmed.ncbi.nlm.nih.gov/40043750/Children's Mercy Hospital Kansas City
Lead Sponsor
University of Kansas Medical Center
Collaborating Sponsor
