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Opioid Antagonist

Naltrexone for Eating Disorders (NN-RCT Trial)

Q: Is this research actively seeking participants?

Affirmative. As per the data available on clinicaltrials.gov, this study is currently enrolling patients which was initially published on September 17th 2022 and most recently updated October 17th 2022. The trial necessitates 60 participants to be recruited from one site in particular.

Q: Is it permissible for me to partake in this research project?

Searchers are currently looking to enrol 60 subjects with eating disorders between the ages of 13 and 21. Crucially, applicants must meet a suite of criteria such as having an accepted DSM-V diagnosis for their disorder, not making any medication changes in the past 4 weeks, and being willing to provide informed permission/assent/consent (if under 18).

Q: How many individuals are being monitored in the current research trial?

Affirmative. The clinical trial in question is still open to participants and recent edits were made on October 17th, 2022 according to the information provided by ClinicalTrials.gov. A total of 60 patients must be recruited from a single location for this research endeavour.

Q: Does the research team have any age restrictions for participants?

This medical trial stipulates that only patients aged 13 to 21 can be included in the study, as outlined by its inclusion criteria.

Phase < 1

Recruiting

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 blood sampled 0-7 hours post medication

Awards & highlights

NN-RCT Trial Summary

This trial will study whether fMRI can detect changes in the brain's reward pathway caused by naltrexone, an opioid antagonist, in adolescents with eating disorders.

Who is the study for?

Adolescents and young adults aged 13-21 with an eating disorder characterized by binge eating and/or purging can join this trial. They must have a stable medication regimen, be able to give informed consent, and not be allergic to naltrexone or pregnant. Those with metal implants incompatible with MRI or recent opioid use are excluded.Check my eligibility

What is being tested?

The study is testing if fMRI can show changes in the brain's reward system when given Naltrexone, an opioid blocker, compared to a placebo. Participants will randomly receive either Naltrexone or placebo first, then switch to the other after a period of time.See study design

What are the potential side effects?

Naltrexone may cause nausea, headache, dizziness, fatigue, insomnia or anxiety. It might also trigger withdrawal symptoms in those who've recently used opioids.

NN-RCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood sampled 0-7 hours post medication

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood sampled 0-7 hours post medication

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood sampled 0-7 hours post medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response

Secondary outcome measures

Area Under the Plasma Concentration vs. Time Curve (AUC)

Maximum Concentration in Plasma (Cmax)

NN-RCT Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment2 Interventions

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.

Group II: Group AExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone

2005

Completed Phase 4

~2420

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterOTHER

463 Previous Clinical Trials

169,210 Total Patients Enrolled

1 Trials studying Eating Disorders

13 Patients Enrolled for Eating Disorders

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,739 Total Patients Enrolled

1 Trials studying Eating Disorders

13 Patients Enrolled for Eating Disorders

Media Library

Naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05509257 — Phase < 1

Eating Disorders Research Study Groups: Group B, Group A

Eating Disorders Clinical Trial 2023: Naltrexone Highlights & Side Effects. Trial Name: NCT05509257 — Phase < 1

Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509257 — Phase < 1

Frequently Asked Questions

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

Is this research actively seeking participants?

"Affirmative. As per the data available on clinicaltrials.gov, this study is currently enrolling patients which was initially published on September 17th 2022 and most recently updated October 17th 2022. The trial necessitates 60 participants to be recruited from one site in particular."

Answered by AI

Is it permissible for me to partake in this research project?

"Searchers are currently looking to enrol 60 subjects with eating disorders between the ages of 13 and 21. Crucially, applicants must meet a suite of criteria such as having an accepted DSM-V diagnosis for their disorder, not making any medication changes in the past 4 weeks, and being willing to provide informed permission/assent/consent (if under 18)."

Answered by AI

How many individuals are being monitored in the current research trial?

"Affirmative. The clinical trial in question is still open to participants and recent edits were made on October 17th, 2022 according to the information provided by ClinicalTrials.gov. A total of 60 patients must be recruited from a single location for this research endeavour."

Answered by AI