Naltrexone Neuroimaging in Teens With Eating Disorders

NCT05509257 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00002228K23MH130728
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response

  Acute %Blood oxygenation level dependent (BOLD) change placebo vs. naltrexone in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex)

  2 hours post medication (naltrexone or placebo)

Secondary Outcomes (2)

• Maximum Concentration in Plasma (Cmax)

  Blood sampled 0-7 hours post medication

• Area Under the Plasma Concentration vs. Time Curve (AUC)

  Blood sampled 0-7 hours post medication

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Naltrexone; Drug: Placebo

Group B

EXPERIMENTAL

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.

Drug: Naltrexone; Drug: Placebo

Interventions

Naltrexone DRUG

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.

Group A; Group B

Placebo DRUG

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.

Group A; Group B

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Kansas Medical Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Mercy Research Institute

Kansas City, Missouri, 64108, United States

RECRUITING

Related Publications (1)

• Stancil SL, Brewe ME, Tumberger J, Bartkoski M, Burns A, Yeh HW, Brucks MG, Bartolotti J, Voss M, Strawn JR, Abdel-Rahman S, Davis A, Brooks WM, Martin LE. Development of a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders: Study protocol for the naltrexone neuroimaging randomized controlled trial (NN-RCT). Contemp Clin Trials. 2025 May;152:107874. doi: 10.1016/j.cct.2025.107874. Epub 2025 Mar 3.

  PMID: 40043750 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia; Bulimia Nervosa; Anorexia Nervosa

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Stephani Stancil, PhD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah L Brewe, BA

CONTACT

(816) 916-3409; mbrewe@cmh.edu

Stephani Stancil, PhD

CONTACT

slstancil@cmh.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: September 17, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)