Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04935931 |
Other study ID # |
STUDY00001668 |
Secondary ID |
UL1TR002366 |
Status |
Completed |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
July 16, 2021 |
Est. completion date |
June 30, 2022 |
Study information
Verified date |
October 2023 |
Source |
Children's Mercy Hospital Kansas City |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This is an open-label, interventional trial to evaluate reward system modulation (detected by
neuroimaging) in response to opioid antagonism (i.e., naltrexone) in adolescents aged 13-21
years with an eating disorder characterized by the target behaviors of binge eating and/or
purging (e.g., AN-BP, BN, BED). A pre/post design completed on the same day will be employed
to quantify within-individual change while reducing potential confounding due to known
neuroimaging variables (e.g., menstrual phase, treatment changes) that may occur with time
elapsed between study visits. Self-report data regarding will be captured via electronic
surveys using validated instruments (where possible), structured interview, study records.
Reward System Modulation by fMRI. Each scan will last approximately 1 hour and involve two
reward activation paradigms: passive food view (PFV) and monetary incentive delay (MID).
These two reward activation paradigms provide distinct insight and will generate pilot data
to support the choice of the optimal paradigm for further testing of reward system modulation
in adolescents with eating disorders. PFV provides a paradigm that is relevant to the target
behaviors (i.e., binge eating, purging), has been evaluated in ED patients, in response to
naltrexone in adults, and is expected to activate food cue-reactivity regions (e.g.,
prefrontal cortex). MID is a widely used paradigm in adolescents to detect reward
anticipation and receipt particularly in the striatum and is currently being used to study
the developmental trajectory of reward processing in the longitudinal Adolescent Brain
Cognitive Development (ABCD) trial. To the greatest extent possible, we will harmonize our
fMRI parameters with those published for ABCD.
Opioid Antagonism and exposure-response linkage. A single oral dose of naltrexone
hydrochloride 50 mg tablet will be administered. Plasma and urine will be obtained to measure
systemic exposure to naltrexone and it primary, active metabolite, 6-beta-naltrexol, using a
validated UPLC-MS/MS assay.