Naltrexone for Bulimia Nervosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Mercy Research Institute, Kansas City, MO
Bulimia Nervosa+9 More
Naltrexone - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
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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).

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Blood sampled 0-7 hours post medication

Hour 2
Response
Hour 7
Area Under the Plasma Concentration vs. Time Curve (AUC)
Maximum Concentration in Plasma (Cmax)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Naltrexone
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Naltrexone · Has Placebo Group · Phase < 1

Naltrexone
Drug
ActiveComparator Group · 1 Intervention: Naltrexone · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: blood sampled 0-7 hours post medication
Closest Location: Children's Mercy Research Institute · Kansas City, MO
Photo of kansas city 1Photo of kansas city 2Photo of kansas city 3
2022First Recorded Clinical Trial
1 TrialsResearching Bulimia Nervosa
1 CompletedClinical Trials

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
223 Previous Clinical Trials
1,268,816 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 13 and 21 years.
You have been on the same medication for at least 4 weeks.
You are willing and able to provide informed consent for the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.