Alcohol Disorder hOsPital Treatment Trial

Completed · Phase 4

Conditions studied: Heavy Drinking, Alcohol Dependence, Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT02478489

Run by

Boston University

People needed

248

Starts

2016-06-01

Expected to finish

2020-10-01

Last updated by the study team

2021-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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*

You may not qualify if…

• 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]

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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