Naltrexone Neuroimaging

Completed · Early Phase 1

Conditions studied: Eating Disorders, Binge Eating, Purging (Eating Disorders)

In brief

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.

Key facts

Study ID

NCT04935931

Run by

Children's Mercy Hospital Kansas City

People needed

13

Starts

2021-07-16

Expected to finish

2022-06-30

Last updated by the study team

2023-10-12

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Mercy Research Institute — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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