Naltrexone Neuroimaging in Teens With Eating Disorders
Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents With Eating Disorders
Children's Mercy Hospital Kansas City
60 participants
Sep 17, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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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Interventions
Participants will receive a single oral dose in randomized, crossover fashion with a 2 week wash out period between interventions. Medication will be taken 2 hours prior the neuroimaging.
Participants will receive a single oral dose of medication in randomized, crossover fashion with a 2 week wash out period between interventions.. Medication will be taken 2 hours prior the neuroimaging.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05509257