← Back to Search

Opioid Antagonist

Naltrexone for Alcoholism

Phase 4

Waitlist Available

Led By David Hui, MD

Research Sponsored by Albert Einstein Healthcare Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

Patients who will be admitted to the hospital

Decompensated liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

Drug Has Already Been Approved

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is proposing a way to connect patients who come to the emergency room with alcohol use disorder to outpatient care in order to try and decrease problematic drinking.

Who is the study for?

This trial is for adults over 18 who show up at the emergency department with alcohol-related issues, want to cut down or stop drinking, and have an AUDIT score of 16 or higher. It's not for those with severe liver disease, allergies to naltrexone, pregnant women, prisoners, non-English speakers without contact means, opioid users, or anyone unable to consent.

What is being tested?

The study tests if starting oral naltrexone in the emergency department can help link patients with alcohol use disorder to outpatient therapy. Success will be measured by how many follow-up for Vivitrol injections at a community center and continue treatment.

What are the potential side effects?

Naltrexone may cause nausea, headache, dizziness or fatigue. Since it affects how the body responds to alcohol and opioids, it could also lead to withdrawal symptoms in people dependent on these substances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I will be admitted to the hospital.

Select...

My liver is not working properly.

Select...

I do not speak English.

Select...

I am unable to give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful referral and follow-up in MAT clinic

Secondary study objectives

Alcohol use severity measures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ParticipantExperimental Treatment1 Intervention

All participants who meet inclusion criteria will be offered oral naltrexone in the ED, a bridge prescription for oral naltrexone, and be referred to outpatient MAT clinic where participants will be offered monthly IM naltrexone injections.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone

FDA approved

0 / 5Eligibility criteria met