NCT04935931

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

June 15, 2021

Results QC Date

July 31, 2023

Last Update Submit

October 10, 2023

Conditions

Eating DisordersBinge EatingPurging (Eating Disorders)

Keywords

PediatricAdolescentEating DisorderNeuroimagingNaltrexone

Outcome Measures

Primary Outcomes (2)

  • Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens

    Change in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens

    2 hours post-naltrexone vs baseline

  • Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex

    Change in %BOLD following single dose naltrexone (post-pre) within individuals during monetary incentive delay in dorsal anterior cingulate cortex

    2 hours post-naltrexone vs baseline

Secondary Outcomes (1)

  • Exposure

    2 hours post-naltrexone

Study Arms (1)

Pilot

EXPERIMENTAL

Pre/post fMRI

Drug: Naltrexone

Interventions

NaltrexoneDRUG

naltrexone 50 mg PO x 1

Pilot

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Research Institute

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • Stancil SL, Yeh HW, Brucks MG, Bruce AS, Voss M, Abdel-Rahman S, Brooks WM, Martin LE. Potential biomarker of brain response to opioid antagonism in adolescents with eating disorders: a pilot study. Front Psychiatry. 2023 Jul 10;14:1161032. doi: 10.3389/fpsyt.2023.1161032. eCollection 2023.

    PMID: 37492067DERIVED

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagia

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Stephani Stancil
Organization
Children's Mercy Kansas City
slstancil@cmh.edu
816-234-3000

Study Officials

  • Stephani Stancil, PhD

    Children's Mercy Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

July 16, 2021

Primary Completion

June 15, 2022

Study Completion

June 30, 2022

Last Updated

October 12, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-10

Locations

US(1)