Viewing Study NCT04345718



Ignite Creation Date: 2024-05-06 @ 2:31 PM
Last Modification Date: 2024-10-26 @ 1:32 PM
Study NCT ID: NCT04345718
Status: RECRUITING
Last Update Posted: 2024-06-17
First Post: 2020-04-09

Brief Title: EXHIT ENTRE Comparative Effectiveness Trial
Sponsor: Hennepin Healthcare Research Institute
Organization: Hennepin Healthcare Research Institute

Study Overview

Official Title: Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Comparative Effectiveness Trial of Extended Release Buprenorphine Versus Treatment as Usual for Hospitalized Patients With Opioid Use Disorder
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXHITENTRE
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 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
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 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 11 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5UG1DA040316-05 NIH None httpsreporternihgovquickSearch5UG1DA040316-05