This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.
The study will randomize approximately 314 hospitalized men and women ages 18 years and older with opioid use disorder (OUD) moderate or severe and who have not been taking prescribed medication for OUD (MOUD) for 14 days or more prior to hospitalization. Eligibility will be determined over one or more assessments during the index hospitalization. Once eligibility has been determined, participants will be randomized 1:1 to either a single injection of extended-release buprenorphine or TAU, which will include methadone, sublingual buprenorphine, or naltrexone. Connection to OUD care and ongoing MOUD following hospitalization will be per community standard. Participants will be assessed for engagement in OUD treatment by the presence of a legitimately prescribed MOUD on day 34 following hospital discharge. Further outcomes will be assessed at 90 and 180 days following hospital discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone).
Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
Yale New Haven Hospital
New Haven, Connecticut, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
Engagement in OUD is defined as coverage with a legitimately prescribed MOUD on that 34th day regardless of the source of prescribed MOUD coverage (e.g., formalized treatment program, primary care, jail, etc.).
Time frame: 34 days post discharge from hospital
Proportion of participants that experience Adverse Events (AE)
34-days following hospital discharge
Time frame: 34 days
Proportion of participants engaged with MOUD
90- and 180-days following hospital discharge
Time frame: Days 90 and 180 post hospital discharge
Proportion of participants with positive urine drug test
for illicit opioids 34-, and 90-, and 180-days following hospital discharge
Time frame: Days 34, 90 and 180 post hospital discharge
Proportion of participants with self-reported opioid use
Time frame: Days 34, 90 and 180 post hospital discharge
Self-reported 30- and 90-day hospital readmission rates
Time frame: Days 30 and 90 post hospital discharge
Self-reported 30- and 90-day Emergency Department (ED) visit rates
Time frame: Days 30 and 90 post hospital discharge
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