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Opioid Antagonist

Naltrexone for Eating Disorders (EDIT-N2 Trial)

Phase < 1
Waitlist Available
Led By Stephani Stancil, PhD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post-naltrexone
Awards & highlights

EDIT-N2 Trial Summary

This study is evaluating whether fMRI can be used to measure the effects of opioid antagonism in adolescents with eating disorders.

Eligible Conditions
  • Eating Disorders
  • Binge Eating
  • Purging Disorder

EDIT-N2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post-naltrexone
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post-naltrexone for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Dorsal Anterior Cingulate Cortex
Change in % Blood Oxygenation Level Dependent Change (%BOLD) in the Nucleus Accumbens
Secondary outcome measures
Exposure

Side effects data

From 2011 Phase 4 trial • 165 Patients • NCT00006489
24%
Nausea
12%
Headache
12%
Cold
10%
Dry Mouth
10%
Fatigue
7%
Gastrointestinal Issues
7%
Muscle Aches
7%
Vomiting
7%
Serious Suicidal Ideation
5%
Constipation
5%
Diarrhea
5%
Stomach Virus
5%
Changes to Vision
5%
Loose Stool
5%
Increased Irritability
5%
Sedation
5%
Stomach Pain
5%
Increased Bowel Movements
2%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naltrexone + Supportive Counseling
Naltrexone + CBT (Prolonged Exposure Therapy)
Placebo + CBT (Prolonged Exposure Therapy)
Placebo + Supportive Counseling

EDIT-N2 Trial Design

1Treatment groups
Experimental Treatment
Group I: PilotExperimental Treatment1 Intervention
Pre/post fMRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterOTHER
463 Previous Clinical Trials
169,257 Total Patients Enrolled
1 Trials studying Eating Disorders
60 Patients Enrolled for Eating Disorders
Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,786 Total Patients Enrolled
1 Trials studying Eating Disorders
60 Patients Enrolled for Eating Disorders
National Center for Advancing Translational Sciences (NCATS)NIH
322 Previous Clinical Trials
401,750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Kansas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Naltrexone Neuroimaging
Stephani Stancil 2021. "Naltrexone Neuroimaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935931.
~3 spots leftby Apr 2025
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