Recruiting

Early Phase 1

NaltrexoneNaltrexone Neuroimaging in Teens With Eating Disorders

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT05509257

Conditions

Eating Disorders

Binge Eating

Purging (Eating Disorders)

Bulimia Nervosa

Anorexia Nervosa, Atypical

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Interventions

Naltrexone

Placebo

Study Details

Brief summary:

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

Study ID

NCT05509257

Start date

Sep 17, 2022

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group A

All participants will receive both naltrexone and placebo, separated by a washout period, in a randomized, crossover fashion. Those randomized to group A will receive naltrexone then placebo. Those randomized to group B will receive placebo then naltrexone.

experimental: Group B

Interventions

Naltrexone

Participants will receive a single oral dose in randomized, crossover fashion with a 2 week wash out period between interventions. Medication will be taken 2 hours prior the neuroimaging.

Placebo

Participants will receive a single oral dose of medication in randomized, crossover fashion with a 2 week wash out period between interventions.. Medication will be taken 2 hours prior the neuroimaging.

Primary outcome measure

Response [ Time Frame: 2 hours post medication (naltrexone or placebo) ]

Central Contacts and Locations

Central contacts

Mariah L Brewe, BA

(816) 916-3409 mbrewe@cmh.edu

Stephani Stancil, PhD

slstancil@cmh.edu

Locations

Children's Mercy Research Institute

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Mariah Brewe, BA

(816) 916-3409 mbrewe@cmh.edu

Principal Investigator:

Stephani L Stancil, PhD, APRN

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

Pediatric
Adolescent
Eating Disorder
Neuroimaging
Naltrexone
Pharmacodynamic Biomarker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2025-11-25.