Naltrexone Neuroimaging

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this open-label, pilot study is to evaluate fMRI as a biomarker of opioid antagonism in adolescents with ED. Modulation of brain activation will be examined in regions of interest by fMRI using a food-specific and general reward task in adolescents with ED in a pre/post design.

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

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Collaborator: University of Kansas Medical Center
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Eating disorder diagnosis per DSM-V criteria that is characterized by binge eating (defined as loss of control of eating resulting in large amount of food consumed in a short period of time) and/or purging (e.g., vomiting, excessive exercising, laxative use)

• 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

• 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.