Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder

NCT ID: NCT04094584

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2022-05-01

Brief Summary

This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED.

Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and there is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD. The rationale for including each component of the multimodal treatment is outlined below.

Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent.

ED patients with alcohol use disorders frequently suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs.

Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar with community treatment resources and are well versed in providing facilitated referrals.

The primary hypothesis is that implementing this multimodal treatment will be feasible in an ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention, continuation of treatment after the trial) are the primary outcomes. The intent of the intervention is to change drinking behavior in a way that benefits participants' health and quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy will be assessed by comparing alcohol consumption, quality of life, and life consequences related to alcohol use before and after the intervention.

The primary efficacy outcome is change in total alcohol consumption measured by a 2 week timeline follow back. Change from baseline will be assessed after the 3 month intervention period, and at the conclusion of the study follow up period for all outcomes.

Conditions

Alcohol Use Disorder; Substance Use; Alcohol Abuse or Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multimodal Intervention

The intervention is multimodal and consists of:

1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months.

2. Case Management services

Group Type: EXPERIMENTAL

Vivitrol (Extended Release Naltrexone)

Intervention Type: DRUG

Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant

Interventions

Vivitrol (Extended Release Naltrexone)

Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant

Intervention Type: DRUG

Other Intervention Names

Case Management; SBIRT

Eligibility Criteria

Inclusion Criteria

• Active alcohol use by self-report
• Known alcohol use disorder or suspected alcohol use disorder and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4, or frequent emergency department visits and hazardous drinking defined as: At least 3 emergency department visits in the past 12 months, including the index visit, and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4

Exclusion Criteria

• Opioid use: currently receiving opioid analgesics, self-report of opioid use in past 7 days, current physiologic opioid dependence, patients in acute opioid withdrawal, urine toxicology screen positive for opiates including fentanyl
• History of hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent
• Liver function tests (AST, ALT) > 5x upper limit of normal or known cirrhosis
• Platelets less than 100,000 per cubic mm
• Acute condition at the time of enrollment that necessitates medical therapy with opioids
• Pregnant
• Incarcerated

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carestar Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Raven, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Charles E Murphy IV, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Murphy CE 4th, Coralic Z, Wang RC, Montoy JCC, Ramirez B, Raven MC. Extended-Release Naltrexone and Case Management for Treatment of Alcohol Use Disorder in the Emergency Department. Ann Emerg Med. 2023 Apr;81(4):440-449. doi: 10.1016/j.annemergmed.2022.08.453. Epub 2022 Oct 31.

Reference Type: DERIVED

PMID: 36328851 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-26090

Identifier Type: -

Identifier Source: org_study_id