Bridging ED to Outpatient AUD Therapy With Naltrexone
Public ClinicalTrials.gov record NCT05228418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05228418
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2022
- Primary completion
- Nov 30, 2024
- Completion
- Jun 30, 2025
- Last update posted
- Feb 7, 2022
2022 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Albert Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania | 19141 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05228418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05228418 live on ClinicalTrials.gov.