Naltrexone Neuroimaging Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Using a randomized, placebo-controlled, crossover study, this study will evaluate 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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Adolescents and young adults aged 13-21 years

• DSM-V 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)

• 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 MR 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.