Naltrexone for Alcoholism

Recruiting in Palo Alto (17 mi)

Overseen byDavid Hui, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Albert Einstein Healthcare Network

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Alcohol use disorder (AUD) is a treatable and common condition encountered in the emergency department, but unfortunately is rarely directly addressed in emergency departments nationwide. To our knowledge, initiation of medication assisted therapy (MAT) for AUD in the emergency department setting has not been widely adopted. Our project is novel for its scope to use a medication well-tested in the outpatient environment and bring it to the emergency department in order to more effectively link patients to outpatient alcohol use reduction therapy as part of a medication assisted therapy (MAT). The investigators are proposing a feasibility project to initiate oral naltrexone to eligible ED patients deemed to have alcohol use disorder and who are interested in cutting down their drinking. The investigators plan to connect these patients with outpatient follow-up in our own community practice center (CPC) for intramuscular (IM) Vivitrol injections under the supervision of the Einstein Toxicology Department. Through the CPC, patients can also be referred to other supporting services such as Alcoholics Anonymous for multidisciplinary care. The investigators are optimistic that this innovative warm hand off from the initial ED visit to outpatient follow-up will ultimately decrease problematic drinking, improve patient's health, and benefit the hospital. Our main objective is to establish a pathway to encourage patients who present to the emergency room with acute sequelae of alcohol use disorder to enter outpatient treatment. Our intervention will be the initiation of oral naltrexone with warm handoff to the Community Practice Center where patients will be transitioned to intramuscular (IM) Vivitrol for chronic maintenance therapy. Thus success will be measured by primarily: percentage of patients who make it to their first outpatient visit for the Vivitrol injection, percentage of patients who continue with treatment and continue to receive Vivitrol for their second injection.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I want to cut down or stop drinking alcohol.

AUDIT score greater or equal to 16

+1 more

Exclusion Criteria

Elevated liver transaminase (AST or ALT) that is greater than 5 times the upper limit of normal

I will be admitted to the hospital.

My liver is not working properly.

+10 more

Participant Groups

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.

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.

Naltrexone is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Vivitrol for: