Alcohol Disorder hOsPital Treatment Trial
Condition: Heavy Drinking; Alcohol Dependence; Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Oral naltrexone (PO-NTX); Extended-release injectable naltrexone (XR-NTX)
Intervention description: oral naltrexone; injectable naltrexone
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alcohol; heavy drinking; naltrexone; hospital; alcohol use disorder; alcohol dependence; comparative effectiveness

Summary:

      The specific aims of this pragmatic randomized controlled trial are to compare initiating
      injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of
      discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1)
      alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital
      readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the
      investigators will assess moderators of medication effects including demographic, behavioral,
      and genetic factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 alcohol use disorder
             (AUD) (assessed using Alcohol Use Disorder and Associated Disabilities Interview
             Schedule (AUDADIS))

          -  ≥1 heavy drinking episodes (≥5 standard drinks [4 for women] in a day) in 30 days
             prior to hospitalization*

          -  Inpatient on a hospital general medical service

          -  Adult (age 18 years or greater)

          -  Ability to speak English (fluency)

          -  ≥2 contact persons*

        Exclusion Criteria:

          -  Pregnancy (urine testing if childbearing potential)

          -  Currently breast-feeding

          -  Urine expanded panel drug test (dipstick) positive for opiates, semi-synthetic or
             synthetic opioids

          -  Opioid use (self-report and verification in medical record) in past 7 days for
             long-acting opioids

          -  Opioid use in past 24 hours for short-acting opioids

          -  Discharge prescription for opioids

          -  Future need for opioids for an anticipated painful event or surgery

          -  Known hypersensitivity to NTX

          -  Acute severe psychiatric illness (currently suicidal or psychotic)

          -  Cognitive dysfunction that precludes informed consent or research assistant (RA)
             assessment that subject cannot understand interview questions

          -  Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of
             normal

          -  Acute hepatitis

          -  Liver failure

          -  Known severe thrombocytopenia (<50,000)

          -  Coagulopathy

          -  Coagulation disorder

          -  Body habitus that precludes intramuscular injection

          -  Plans to leave the Boston area in less than one year

          -  Enrollment in a research study which involves taking a pharmaceutical agent that is
             expected to interact with naltrexone

        [*criteria not changed since study start; change reflects correction of typo]