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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for study enrollment:

1. English or Spanish speaking*

*Non-English Spanish speaking patients will not be enrolled initially until study documents have been translated, back translated, and approved by the Institutional Review Board (IRB).

2. Emergency Department patient

3. Aged 18-80

4. Have had >4 emergency department visits within 12 months for 2 consecutive 12-month periods. Period of time can be extended by up to 6 months if incarcerated or institutionalized for ≥ 6 months.

5. Meet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcohol dependence or & DSM-V criteria for alcohol use disorder, severe.

6. Have ≥2 days/week of heavy drinking (>4 drinks/day)

7. Capable of giving informed consent.

Exclusion Criteria

Subjects who meet any of the following criteria will be ineligible for study enrollment:

1. Active opioid dependence

2. Acute or chronic pain requiring opioid treatment

3. Acute liver injury (liver aminotransferase concentrations >5 times the upper limit of normal)

4. Health condition considered unsafe for inclusion (at discretion of PI and/or attending physician)

5. Lack of capacity or willingness to consent

6. Currently prescribed pharmacotherapy for alcohol dependence (not including treatment of acute alcohol withdrawal syndrome)

7. Previous significant adverse reaction to naltrexone or diluent

8. Pregnant, nursing, or not using effective methods of birth control

9. Prisoners (as defined by Office of Human Research Protection) at the time of enrollment ARE NOT ELIGIBLE for study entry. However, subjects who become prisoners after being enrolled will be included and not be withdrawn from the study. Patients on parole or probation are eligible for enrollment.