Using Naltrexone and fMRI to Study Eating Disorders in Teens
Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents With Eating Disorders
This study is testing if the medication naltrexone can change how the brain responds to rewards in teens with eating disorders to help find better treatments.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Mercy Hospital Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT05509257 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of naltrexone, an opioid antagonist, on the reward pathways in adolescents with eating disorders using functional magnetic resonance imaging (fMRI). It employs a randomized, placebo-controlled, double-blind, crossover design to assess how naltrexone modulates brain activity in specific regions associated with reward processing. Participants aged 13-21 with binge/purge behaviors will be monitored to determine the pharmacodynamic response to the drug. The goal is to develop an objective biomarker for early-phase pharmacology studies of treatments targeting the reward system in eating disorders.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-21 diagnosed with eating disorders characterized by binge eating and/or purging behaviors.
Not a fit: Patients who are pregnant, have a history of hypersensitivity to naltrexone, or have current opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for adolescents with eating disorders by providing a measurable response to pharmacological interventions.
How similar studies have performed: While the use of fMRI in this context is innovative, similar studies have shown promise in understanding the neurobiological underpinnings of eating disorders.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kansas City, Missouri
- Children's Mercy Research Institute — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Stephani Stancil, PhD — Children's Mercy Hospital Kansas City
- Study coordinator: Mariah L Brewe, BA
- Email: mbrewe@cmh.edu
- Phone: (816) 916-3409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.