NCT05509257 · Children's Mercy Hospital Kansas City
Naltrexone Neuroimaging in Teens With Eating Disorders
(NN-RCT)
What this study is about
Using a randomly assigned, compared against an inactive treatment, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a how the drug affects the body biomarker of opioid antagonism in adolescents with eating disorders.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Kansas City, Missouri
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2025 · Source of record for eligibility and locations