Naltrexone Neuroimaging in Teens With Eating Disorders

Eating Disorders Clinical Trial

— NN-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509257
• Other study ID #: STUDY00002228
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 17, 2022
• Est. completion date: June 2027

Study information

• Verified date: October 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: John Tumberger, BS
• Phone: 8164829872
• Email: jtumberger[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Children's Mercy Research Institute	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Concentration in Plasma (Cmax)	Naltrexone systemic exposure defined by the pharmacokinetic parameter Cmax	Blood sampled 0-7 hours post medication
Secondary	Area Under the Plasma Concentration vs. Time Curve (AUC)	Naltrexone systemic exposure defined by the pharmacokinetic parameter AUC	Blood sampled 0-7 hours post medication