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Recruiting EARLY_Phase 1 NCT05509257

Naltrexone Neuroimaging in Teens With Eating Disorders

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Trial Parameters

Condition Eating Disorders
Sponsor Children's Mercy Hospital Kansas City
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 60
Sex ALL
Min Age 13 Years
Max Age 21 Years
Start Date 2022-09-17
Completion 2026-09
Interventions
NaltrexonePlacebo

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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.

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