Status:
TERMINATED
Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Carestar Foundation
Conditions:
Alcohol Use Disorder
Substance Use
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
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 alcoho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04094584
Start Date
August 14 2020
End Date
May 1 2022
Last Update
June 22 2023
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94122