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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Missouri
Children's Mercy Research Institute
RECRUITING
Kansas City
Contact Information
Primary
Mariah L Brewe, BA
mbrewe@cmh.edu
(816) 916-3409
Backup
Stephani Stancil, PhD
slstancil@cmh.edu
Time Frame
Start Date: 2022-09-17
Estimated Completion Date: 2027-06
Participants
Target number of participants: 60
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Kansas Medical Center, National Institute of Mental Health (NIMH)
Leads: Children's Mercy Hospital Kansas City

This content was sourced from clinicaltrials.gov