Phase 4
N=248
Alcohol Disorder hOsPital Treatment Trial
Heavy Drinking · Alcohol Dependence · Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02478489 ↗Enrolled (actual)
248
Serious AEs
34.7%
Results posted
Jun 2021
Primary outcome: Primary: Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back — -46.4; -38.4 change in percent heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral naltrexone (PO-NTX) (Drug); Extended-release injectable naltrexone (XR-NTX) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back |
-46.4; -38.4 | — |
| SECONDARY Acute Care Hospital Utilization |
66; 59; 42; 50 | — |
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]
Data sourced from ClinicalTrials.gov (NCT02478489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.