At a glance
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Novel Interventions for Alcohol Dependent Frequent Emergency Department Users: Phase IV, Randomized, Open-label, Non-placebo-controlled Study of Extended-release Naltrexone and Care Management on Healthcare Use, Drinking, & Quality of Life
In Brief
A Phase 4 clinical trial evaluating XR-NTX+CM (Extended-Release Naltrexone plus Care Management) for Alcohol Dependence and Alcohol Use Disorder. Completed, enrolled 50 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.