Bridging ED to Outpatient AUD Therapy With Naltrexone
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05228418 |
Recruitment Status :
Not yet recruiting
First Posted : February 8, 2022
Last Update Posted : February 8, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Use Disorder | Drug: Naltrexone Pill | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bridging ED to Outpatient AUD Therapy With Naltrexone |
Estimated Study Start Date : | March 2022 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | July 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Participant
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.
|
Drug: Naltrexone Pill
Naltrexone oral bridge to IM naltrexone maintenance therapy
Other Name: naltrexone IM 380mg |
- Successful referral and follow-up in MAT clinic [ Time Frame: 4 weeks ]The primary endpoint is percentage of patients who are successfully referred to outpatient MAT treatment in our hospital's outpatient clinic and percentage of people who stay in treatment at the intake and subsequent follow-up outpatient clinic visit. (i.e. % of patients who remain in treatment at the initial outpatient intake visit scheduled within 1 week of the initial index ED visit and the follow-up appointment 4 weeks after the intake visit)
- Alcohol use severity measures [ Time Frame: 4 weeks ]We will track variables that we believe to correlate with alcohol use disorder, such as estimation of weekly alcohol intake, alcohol cravings cravings, ED visits for alcohol use for the previous week via surveys administered during the intake outpatient MAT visit and the follow-up appointment 4 weeks later.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- Presents to the ED with chief complaint of alcohol use or judged to have alcohol use as a significant contributing factor to their presentation to the emergency department
- Patients must be interested in reducing or stopping their alcohol use
- AUDIT score greater or equal to 16
Exclusion Criteria:
- Patients will be excluded if they previously participated in the study
- patients who will be admitted to the hospital
- Endorse dependence on opioid medications or opioid street drugs
- have an extended urine drug screen that is positive for opioids
- elevated liver transaminase (AST or ALT) that is greater than 5 times the upper limit of normal
- decompensated liver disease
- allergic reaction to naltrexone
- pregnant
- prisoners
- unable to provide consent
- subjects in police custody
- non-English speaking
- have no reliable means for future contact.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228418
Contact: David Hui, MD | 510-371-5687 | huidavid@einstein.edu | |
Contact: Serge Simpson, MD | 215-456-6679 | simpsose@einstein.edu |
United States, Pennsylvania | |
Albert Einstein Medical Center Philadelphia | |
Philadelphia, Pennsylvania, United States, 19141 |
Principal Investigator: | David Hui, MD | Albert Einstein Medical Center |
Responsible Party: | David Hui, Resident Physician, Albert Einstein Healthcare Network |
ClinicalTrials.gov Identifier: | NCT05228418 |
Other Study ID Numbers: |
2021-546 |
First Posted: | February 8, 2022 Key Record Dates |
Last Update Posted: | February 8, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone |
Alcohol Deterrents Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |