NCT04094584

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

Terminated Phase 4 Results posted Last updated 22 June 2023

What this trial tests

Phase 4 trial testing Vivitrol (Extended Release Naltrexone) in Alcohol Use Disorder in 179 participants. Terminated before completion.

Timeline

14 August 2020

Primary endpoint
1 May 2022

1 May 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	179
Start date	14 August 2020
Primary completion	1 May 2022
Estimated completion	1 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Vivitrol (Extended Release Naltrexone) — full drug profile →

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Substance Use — all drugs for Substance Use →
• Alcohol Abuse or Dependence — all drugs for Alcohol Abuse or Dependence →

Sponsor

University of California, San Francisco

Who can join

21 and older, any sex, with Alcohol Use Disorder or Substance Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants Retained in Study at 3 Months Primary · 3 months

Percentage of enrolled participants who attend final study visit at the end of the intervention period

Group	Value	95% CI
Multimodal Intervention	27

Change in Daily Total Alcohol Consumption From Baseline at 3 Months Primary · 3 months after enrollment

Self-reported total daily alcohol consumption at 3 months, compared to baseline

Group	Value	95% CI
Multimodal Intervention	-7.5	-8.6 – -5.9

Change in Quality of Life Score at 3 Months Secondary · 3 months after enrollment

Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.

Group	Value	95% CI
Multimodal Intervention	1.2	0.5 – 1.9

Continued Naltrexone Use After Intervention Period Secondary · 3 months

Percentage of enrolled who self reported continuing treatment with naltrexone through their primary physician after the end of the study intervention period

Group	Value	95% CI
Multimodal Intervention	22

Change in WHO Drinking Risk Level Secondary · 3 months after enrollment

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

Group	Value	95% CI
Multimodal Intervention	-2	-3 – 0

Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R) Secondary · 3 months after enrollment

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)

Group	Value	95% CI
Multimodal Intervention	-13	-19 – -7

Receipt of All Study Naltrexone Injections Secondary · 3 months

Percentage of participants receiving all 3 scheduled naltrexone injections received

Group	Value	95% CI
Multimodal Intervention	23

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.