Overview

Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users

Status:
Active, not recruiting

Trial end date:
2023-01-01

Target enrollment:

Participant gender:

Summary

Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).

Phase:

Phase 4

Details

Lead Sponsor:

New York University School of Medicine
NYU Langone Health

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Treatments:

Ethanol
Naltrexone
Peripheral Nervous System Agents