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

PHASE4CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

February 8, 2019

Study Completion Date

February 8, 2019

Conditions
Alcohol DependenceAlcohol Use Disorder
Interventions
DRUG

XR-NTX+CM (Extended-Release Naltrexone plus Care Management)

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.

Trial Locations (1)

10016

Bellevue Hospital Center, New York

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

NYU Langone Health

OTHER

NCT02445339 - Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users | Biotech Hunter | Biotech Hunter