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

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

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.

Study Overview

• Status: Terminated
• Conditions: Substance Use; Alcohol Use Disorder; Alcohol Abuse or Dependence
• Intervention / Treatment: Drug: Vivitrol (Extended Release Naltrexone)

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94122
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Intervention; The intervention is multimodal and consists of: Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months.; Case Management services	Drug: Vivitrol (Extended Release Naltrexone); Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant; Other Names: SBIRT; Case Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Retained in Study at 3 Months	Percentage of enrolled participants who attend final study visit at the end of the intervention period	3 months
Retention at 12 Months	Percentage of enrolled participants who complete final study visit at the end of the follow up periods	12 months
Change in Daily Total Alcohol Consumption From Baseline at 3 Months	Self-reported total daily alcohol consumption at 3 months, compared to baseline	3 months after enrollment
Change in Total Alcohol Consumption at 12 Months	Change in self-reported total daily alcohol consumption from baseline	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Score at 3 Months	Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.	3 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance Use Treatment Utilization	percentage of participants self-reporting engagement in community substance use treatment programs	12 months
Recruitment	Percentage of those approached who enroll in the study	12 months
Continued Naltrexone Use After Intervention Period	Percentage of enrolled who self reported continuing treatment with naltrexone through their primary physician after the end of the study intervention period	3 months
Change in ED Utilization	Change in the number of emergency department visits determined by electronic medical record review	12 months before and after enrollment
Change in WHO Drinking Risk Level	Change in World Health Organization drinking risk level from baseline. Risk levels are scored 1-4 with higher scores indicating more severe health risk from alcohol use	3 months after enrollment
Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R)	Change in life consequences due to alcohol use from baseline as measured by revised short inventory of problems (score 0-45 with higher scores indicating more severe alcohol related life consequences)	3 months after enrollment
Receipt of All Study Naltrexone Injections	Percentage of participants receiving all 3 scheduled naltrexone injections received	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: The CARESTAR Foundation
• Investigators: Principal Investigator: Maria Raven, MD, University of California, San Francisco; Principal Investigator: Charles E Murphy IV, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Naltrexone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Disease Attributes; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Emergencies; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 18-26090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes