NCT05509257 Naltrexone Neuroimaging in Teens With Eating Disorders
| NCT ID | NCT05509257 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Children's Mercy Hospital Kansas City |
| Condition | Eating Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2022-09-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Stephani Stancil, PhD
PRINCIPAL INVESTIGATOR
Children's Mercy Hospital Kansas City
Frequently Asked Questions
Who can join the NCT05509257 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 21 Years, studying Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05509257 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05509257 currently recruiting?
Yes, NCT05509257 is actively recruiting participants. Contact the research team at mbrewe@cmh.edu for enrollment information.
Where is the NCT05509257 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT05509257 clinical trial?
NCT05509257 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Stephani Stancil, PhD at Children's Mercy Hospital Kansas City. The trial plans to enroll 60 participants.