Naltrexone Neuroimaging in Teens with Eating Disorders

Last updated: November 1, 2024
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Active - Recruiting

Phase

1

Condition

Anorexia

Vomiting

Bulimia

Treatment

Naltrexone

Placebo

Clinical Study ID

NCT05509257
STUDY00002228
K23MH130728
  • Ages 13-21
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adolescents and young adults aged 13-21 years

  • Eating disorder diagnosis characterized by binge eating and/or purging (eg, AnorexiaNervosa-Binge/Purge, Bulimia Nervosa, Binge Eating Disorder, Other SpecifiedFeeding/Eating Disorder) using Diagnostic and Statistical Manual of MentalDisorders, 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 toprovide informed permission/assent/consent for the study

Exclusion

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 precludescommunication and/or ability to complete all study-related requirements.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Naltrexone
Phase: 1
Study Start date:
September 17, 2022
Estimated Completion Date:
June 30, 2027

Study Description

The investigators will use a randomized, placebo-controlled, double-blind, crossover trial to evaluate the use of fMRI as a pharmacodynamic biomarker of reward system modulation. The overall goal of this work is to develop an objective tool to detect acute drug response. If validated in future, larger trials, the pharmacodynamic biomarker may facilitate early phase/quantitative pharmacology studies of novel or repurposed agents expected to modulate the reward system. The reward system will be antagonized by naltrexone in adolescents aged 13-21 years with an ED defined by binge/purge behaviors (e.g., Anorexia Nervosa-Binge Purge, Bulimia Nervosa, Binge Eating Disorder). A crossover design was chosen to quantify within-individual change in opioid reward pathway modulation following antagonism. Eligible patients will be randomly assigned to Group A or Group B. A statistician (or other non-study staff) will generate the schedule and communicate with the investigation drug service to maintain the double-blind design. A washout period of at least 14 days will exceed the 48-hour carry-over effect from naltrexone 50 mg administered orally. The two study visits will be mirrored in structure and duration to maintain blinding.

It is not the intent of this study to generate data for submission to the FDA or to support a significant change in advertising of the drug. Storage, control and dispensation of the drug will occur through collaboration with the investigational drug service (IDS) pharmacy. Use of naltrexone for this study meets criteria for investigational new drug (IND) exemption, category #1 (21 Code of Federal Regulations (CFR) 312.2(b)(1)).

Connect with a study center

  • Children's Mercy Research Institute

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

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