RECRUITING

Naltrexone Neuroimaging in Teens with Eating Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

Official Title

Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents with Eating Disorders

Quick Facts

Study Start:2022-09-17
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05509257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adolescents and young adults aged 13-21 years
  2. * Eating disorder diagnosis characterized by binge eating and/or purging (eg, Anorexia Nervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding/Eating Disorder) using Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria.
  3. * Stable medication regimen (no dose or drug changes in the past 4 weeks)
  4. * Participant and parent/legal guardian (if under 18 years) are willing and able to provide informed permission/assent/consent for the study
  1. * Pregnant (via UCG)
  2. * Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
  3. * Non-removable metal in the body that is magnetic resonance imaging incompatible
  4. * Current naltrexone use
  5. * Self-reported opioid use in the past 7 days
  6. * A language barrier (e.g., non-English speaking) for the participant that precludes communication and/or ability to complete all study-related requirements.

Contacts and Locations

Study Contact

John Tumberger, BS
CONTACT
8164829872
jtumberger@cmh.edu
Stephani Stancil, PhD
CONTACT
slstancil@cmh.edu

Study Locations (Sites)

Children's Mercy Research Institute
Kansas City, Missouri, 64108
United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-17
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-09-17
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Pediatric
  • Adolescent
  • Eating Disorder
  • Neuroimaging
  • Naltrexone
  • Pharmacodynamic Biomarker

Additional Relevant MeSH Terms

  • Eating Disorders
  • Binge Eating
  • Purging (Eating Disorders)
  • Bulimia Nervosa
  • Anorexia Nervosa, Atypical