Emergency Department Initiated Oral Naltrexone for Alcohol Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alcohol Use Disorder+2 More
Emergency Department Initiated Oral Naltrexone - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Alcohol Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alcohol Use Disorder

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Day 30

Day 14
Guidelines Regimen Information Program (GRIP) guide at day 14
Number of participants enrolled and receiving formal addiction treatment at day 14
Number of pills in bottle at day 14
Day 30
AUD Program Satisfaction Survey
Guidelines Regimen Information Program (GRIP) guide at day 30
Health Related Quality of Life (HRQoL)
Health Services Utilization Survey
Number of participants enrolled and receiving formal addiction treatment at day 30
Number of participants who Transition to LA Injectable
Number of pills in bottle at day 30
The Patient Rated Inventory of Side Effects (PRISE) survey
up to 30 days
Daily alcohol craving scale
Number of Heavy Drinking Days
Number of drinks

Trial Safety

Safety Progress

1 of 3

Other trials for Alcohol Use Disorder

Trial Design

1 Treatment Group

Oral Naloxone
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Emergency Department Initiated Oral Naltrexone · No Placebo Group · Phase 1

Oral Naloxone
Drug
Experimental Group · 1 Intervention: Emergency Department Initiated Oral Naltrexone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 30

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
771 Previous Clinical Trials
479,813 Total Patients Enrolled
Ethan Cowan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an emergency department patient who is 18 years of age or older.
You are able to speak and understand English.
You are medically stable for an interview as determined by your primary ED provider.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 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.