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Naltrexone Neuroimaging (EDIT-N2)

Primary Purpose

Eating Disorders, Binge Eating, Purging (Eating Disorders)

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Disorders focused on measuring Pediatric, Adolescent, Eating Disorder, Neuroimaging, Naltrexone

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Mercy Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot

Arm Description

Pre/post fMRI

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Exposure
Maximum plasma concentration of naltrexone at 2 hours post-single dose

Full Information

First Posted
June 15, 2021
Last Updated
October 10, 2023
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
National Center for Advancing Translational Sciences (NCATS), University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04935931
Brief Title
Naltrexone Neuroimaging
Acronym
EDIT-N2
Official Title
Eating Disorder Individualized Therapeutics-Naltrexone Neuroimaging (EDIT-N2)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
National Center for Advancing Translational Sciences (NCATS), University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Binge Eating, Purging (Eating Disorders)
Keywords
Pediatric, Adolescent, Eating Disorder, Neuroimaging, Naltrexone

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot
Arm Type
Experimental
Arm Description
Pre/post fMRI
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
naltrexone 50 mg PO x 1
Primary Outcome Measure Information:
Title
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens
Description
Change in %BOLD following single dose naltrexone (post-pre) within individuals during passive food view task in the nucleus accumbens
Time Frame
2 hours post-naltrexone vs baseline
Title
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex
Description
Change in %BOLD following single dose naltrexone (post-pre) within individuals during monetary incentive delay in dorsal anterior cingulate cortex
Time Frame
2 hours post-naltrexone vs baseline
Secondary Outcome Measure Information:
Title
Exposure
Description
Maximum plasma concentration of naltrexone at 2 hours post-single dose
Time Frame
2 hours post-naltrexone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephani Stancil, PhD
Organizational Affiliation
Children's Mercy Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Naltrexone Neuroimaging

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