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Opioid Antagonist

Oral Naltrexone for Alcoholism

Phase 1
Waitlist Available
Led By Ethan Cowan, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights

Study Summary

This trial will study how to best help Emergency Department patients with AUD start on MAT, using oral naltrexone. They will split the patients into two groups and study how to best help them in each group.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants enrolled and receiving formal addiction treatment at day 14
Number of participants enrolled and receiving formal addiction treatment at day 30
Secondary outcome measures
AUD Program Satisfaction Survey
Daily alcohol craving scale
Guidelines Regimen Information Program (GRIP) guide at day 14
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral NaloxoneExperimental Treatment1 Intervention
Oral Naltrexone initiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emergency Department Initiated Oral Naltrexone
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,265 Total Patients Enrolled
Ethan Cowan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

Naltrexone (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04817410 — Phase 1
Alcoholism Research Study Groups: Oral Naloxone
Alcoholism Clinical Trial 2023: Naltrexone Highlights & Side Effects. Trial Name: NCT04817410 — Phase 1
Naltrexone (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817410 — Phase 1

Frequently Asked Questions

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

In what ways can Emergency Department Initiated Oral Naltrexone help patients?

"Emergency Department Initiated Oral Naltrexone (EDION) is a recommended treatment for the alleviation of symptoms related to opioids, disease, and pain. It may also be used to address physical activity levels if necessary."

Answered by AI

What objectives has this investigation endeavored to accomplish?

"The main aim of this 14-day study is to gauge the number of participants enrolled and receiving addiction treatment at day 30. Additional objectives include assessing adherence to daily oral naltrexone through pill counts, measuring alcohol cravings with a Qualtrics scale (0-36), and using GRIP guide - a self-reported questionnaire - to check adherence at Day 14."

Answered by AI

Has the Federal Drug Administration authorized Emergency Department Initiated Oral Naltrexone?

"Due to the limited data concerning its efficacy and safety, Emergency Department Initiated Oral Naltrexone has been assigned a rating of 1 on our scale from 1-3."

Answered by AI

How many participants are actively enrolled in this research endeavor?

"Absolutely. Clinicaltrials.gov displays that, since the original posting of this clinical trial on September 28th 2021, recruitment is still ongoing. 30 volunteers will be accepted at one centre for the study's duration."

Answered by AI

Are individuals being sought for participation in this scientific investigation?

"Correct. As stated on clinicaltrials.gov, this medical trial is currently seeking participants since its inception on September 28th 2021 and last modification on February 11th 2022. The team needs to find 30 patients from a single site to complete the study's requirements."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Mount Sinai Beth Israel
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
ED Initiated Oral Naltrexone for AUD
Ethan Cowan 2021. "ED Initiated Oral Naltrexone for AUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817410.
~6 spots leftby Apr 2025
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