CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 13 enrolled
Drug / intervention
Naltrexonedrug
Likely dose
Naltrexone 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04935931
NCT04935931Early Ph 1Completed
CompareCT.gov

Eating Disorder Individualized Therapeutics-Naltrexone Neuroimaging (EDIT-N2)

Children's Mercy Hospital Kansas City·interventional·Posted Jun 23, 2021·Updated Oct 12, 2023

In Brief

A Early Phase 1 clinical trial evaluating Naltrexone for Eating Disorders and 2 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEating Disorders, Binge Eating, Purging (Eating Disorders)
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS), University of Kansas Medical Center

Timeline

Early Ph 1CompletedFinished
20222023202420252026
First PostedJun 23, 2021
Enrollment StartJul 16, 2021
Primary CompletionJun 15, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.0 years ago

Interventions

Naltrexonedrug

naltrexone 50 mg PO x 1