- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345718
EXHIT ENTRE Comparative Effectiveness Trial (EXHITENTRE)
February 2, 2024 updated by: Hennepin Healthcare Research Institute
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 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
Enrollment (Estimated)
342
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paulette A Baukol
- Phone Number: 612-873-6993
- Email: pbaukol@bermancenter.org
Study Contact Backup
- Name: Rebecca Kent, MS
- Phone Number: 8155295495
- Email: rkent@bermancenter.org
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Yale New Haven Hospital
-
Contact:
- Jennifer Edelman, MD,MHS
-
Principal Investigator:
- Jennifer Edelman, MD,MHS
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins Bayview Medical Center
-
Contact:
- Megan Buresh, MD
-
Principal Investigator:
- Megan Buresh, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Sarah Wakeman, MD
-
Principal Investigator:
- Sarah Wakeman, MD
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston University
-
Contact:
- Richard Saitz, MD,MPH
-
Principal Investigator:
- Richard Saitz, MD,MPH
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Recruiting
- Hennepin Healthcare Research Institute
-
Contact:
- Gavin Bart, MD,PhD
-
Principal Investigator:
- Gavin Bart, MD,PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
|
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).
Other Names:
|
Active Comparator: Treatment as Usual
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.
|
Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
Time Frame: 34 days post discharge from hospital
|
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.).
|
34 days post discharge from hospital
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants that experience Adverse Events (AE)
Time Frame: 34 days
|
34-days following hospital discharge
|
34 days
|
Proportion of participants engaged with MOUD
Time Frame: Days 90 and 180 post hospital discharge
|
90- and 180-days following hospital discharge
|
Days 90 and 180 post hospital discharge
|
Proportion of participants with positive urine drug test
Time Frame: Days 34, 90 and 180 post hospital discharge
|
for illicit opioids 34-, and 90-, and 180-days following hospital discharge
|
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
|
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
|
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
|
Days 30 and 90 post hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gavin Bart, MD,PhD, Hennepin Heatlhcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.
- Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.
- Trowbridge P, Weinstein ZM, Kerensky T, Roy P, Regan D, Samet JH, Walley AY. Addiction consultation services - Linking hospitalized patients to outpatient addiction treatment. J Subst Abuse Treat. 2017 Aug;79:1-5. doi: 10.1016/j.jsat.2017.05.007. Epub 2017 May 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2021
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
April 9, 2020
First Submitted That Met QC Criteria
April 13, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Narcotic-Related Disorders
- Substance-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Analgesics, Opioid
Other Study ID Numbers
- NIDA CTN 0098A
- 5UG1DA040316-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on the National Institute on Drug Abuse (NIDA) Data Share website.
Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse.
De-identified individual participant data is expected to be made available.
IPD Sharing Time Frame
The data will be shared after the primary outcome paper has been accepted for publication, or 18 months after data lock, whichever comes first.
The data will remain indefinitely.
IPD Sharing Access Criteria
Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed.
This website will not include information that can identify individual study participants.The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes.
Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use.
Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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