Status:
COMPLETED
EXHIT ENTRE Comparative Effectiveness Trial
Lead Sponsor:
Gavin Bart
Collaborating Sponsors:
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
Conditions:
Substance Use Disorder
Opioid Use Disorder, Moderate
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 pat...
Detailed Description
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 O...
Eligibility Criteria
Inclusion
- Hospitalized.
- At least 18 years of age.
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
- Willing to initiate MOUD, including buprenorphine.
- Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Exclusion
- Anticipated length of stay less than 24-hours as determined by the ACS
- Affected by a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make it unsafe to participate in the study or may prevent collection of study data. This may include:
- Disabling terminal diagnosis for which discharge from hospital is not anticipated.
- Disabling terminal diagnosis for which hospice care is being sought.
- Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.
- Taking a long-acting opioid other than buprenorphine (e.g., methadone, extended-release oxycodone, extended-release morphine) in the three consecutive days prior to randomization.
- Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.
- Currently pregnant.
- Known allergy to buprenorphine or components of Atrigel delivery system.
- Receipt of MOUD in the 14 days prior to hospitalization as maintenance treatment; however, patients may have received MOUD for withdrawal management during or prior to hospitalization at the time of enrollment.
- Are currently in jail, prison or other overnight facility as required by court of law and/or is considered a prisoner under local law or is under current terms of civil commitment or guardianship.
- Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT04345718
Start Date
August 9 2021
End Date
August 27 2025
Last Update
December 9 2025
Active Locations (6)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
2
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Boston University
Boston, Massachusetts, United States, 02118