Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
Condition: Alcohol Dependence; Alcohol Use Disorder
MeSH terms: Emergencies; Alcoholism; Alcohol Drinking
Intervention: XR-NTX+CM (Extended-Release Naltrexone plus Care Management)
Intervention description: 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Alcohol Dependence; Alcohol Use Disorder; Care Management; Case Management; Emergency Care Services; Emergency Department; Emergency Room; Extended-release naltrexone; Frequent Users; Health Care Utilization; Medical Management; Naltrexone; Population Health; Public Health; Vivitrol; XR-NTX; XR-NTX+CM; Alcoholism; Alcohol-Related Disorders; Central Nervous System Agents; Chemically-Induced Disorders; Clinical Trial; Emergency Medicine; Mental Disorders; Narcotic Antagonists; Peripheral Nervous System Agents; Pharmacologic Actions; Physiological Effects of Drugs; Sensory System Agents; Substance-Related Disorders

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).
    

Eligibility 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.