Naltrexone Neuroimaging in Teens with Eating Disorders

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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

Naltrexone Neuroimaging in Teens with Eating Disorders

Condition
Eating Disorders
Intervention / Treatment

-

Contacts and Locations

Kansas City

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adolescents and young adults aged 13-21 years
  • * 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.
  • * 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
  • * Pregnant (via UCG)
  • * Prior hypersensitivity reaction to naltrexone (e.g., anaphylaxis)
  • * Non-removable metal in the body that is magnetic resonance imaging incompatible
  • * 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.

Ages Eligible for Study

13 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Mercy Hospital Kansas City,

Study Record Dates

2027-06