Alcohol Disorder hOsPital Treatment Trial

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Naltrexone

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]