Alcohol Use Disorder hOsPital Treatment Trial
Information source: Boston University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heavy Drinking; Alcohol Dependence; Alcohol Use Disorder
Intervention: Oral naltrexone (Drug); extended-release injectable naltrexone (XR-NTX) (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Boston University Official(s) and/or principal investigator(s): Richard Saitz, MD, MPH, Principal Investigator, Affiliation: Boston University
Overall contact: Seville M Meli, MPH, Phone: 6174146917, Email: seville@bu.edu
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.
Clinical Details
Official title: Oral v. Injection Naltrexone in Hospital Comparative Effectiveness for Alcoholism
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: percent heavy drinking days (%HDDs) over the past 30 days assessed at 3 month follow-up by the Timeline Follow-Back
Secondary outcome: Acute care hospital utilization
Detailed description:
Hospitalization for medical illness is a unique and missed opportunity for intervention for
alcohol use disorders (AUDs). Referrals can help link patients from hospitals to alcohol
treatment. But most patients return to heavy drinking after hospital discharge and do not
follow-up with alcohol treatment, risking hospital readmission. Pharmacotherapy has efficacy
for alcohol dependence, but adherence to these medications is poor. Furthermore, these
medications are rarely prescribed in general medical settings, during or after
hospitalization. Beginning treatment for alcohol dependence during a hospitalization for
medical illness could broaden the reach of effective treatment and is likely to be more
effective than delaying treatment until a specialist visit or treatment program entry.
Hospital discharge is a time of both risk (i. e., for drinking and non-adherence to medical
care) and opportunity (i. e., to begin alcohol treatment and complete medical treatments).
Interventions that work quickly and improve adherence could improve medical and
alcohol-related outcomes.
Oral naltrexone (PO-NTX), and the more-costly-per-dose long-acting injectable extended
release naltrexone (XR-NTX) are Food and Drug Administration (FDA)-approved efficacious
treatments for alcohol dependence. The XR-NTX half-life is 5-10 days and is dosed monthly,
whereas the PO-NTX half-life is 13 hours and is dosed daily. The longer half-life of XR-NTX
translates into patients receiving effective pharmacotherapy for a longer time without
having to adhere to a daily dose. Thus, although more costly per dose, greater effectiveness
could mean overall reduced costs of care (including alcohol-related health consequences and
healthcare utilization). Despite potential differences in costs and patient preferences,
PO-NTX and XR-NTX have not been directly compared in a randomized controlled trial (RCT),
they have not been studied as treatments at medical hospital discharge, and their
effectiveness in real world practice settings compared with standard care is unknown.
This trial is significant because it will address the clinically relevant comparative
effectiveness question and lead to greater adoption of the most effective and cost-effective
approach for treating AUD with pharmacotherapy in general hospitals.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 2 days (48 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)
- Serum alanine aminotransferase or aspartate aminotransferase >3 times the upper limit
of normal
- Acute hepatitis
- Liver failure
- Known severe thrombocytopenia (<50,000),
- Coagulopathy (International Normalized Ratio >1. 5)
- Coagulation disorder
- Body habitus that precludes intramuscular injection
- Plans to leave the Boston area in less than one year
Locations and Contacts
Seville M Meli, MPH, Phone: 6174146917, Email: seville@bu.edu Additional Information
Starting date: September 2015
Last updated: June 24, 2015
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