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EXHIT ENTRE Comparative Effectiveness Trial (EXHITENTRE)

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ClinicalTrials.gov Identifier: NCT04345718
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : February 5, 2024
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Substance Use Disorder Opioid Use Disorder, Moderate Opioid Use Disorder, Severe Drug: Extended Release Buprenorphine Drug: Treatment as Usual Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of XR-BUP versus TAU for hospitalized patients with OUD agreeing to MOUD. Approximately 4-5 sites (hospitals) with existing ACSs experienced in hospital-initiated MOUD will be selected. Identification of patients with OUD will occur as per each site's local practice. Approximately 314 hospitalized patients with OUD who were not receiving prescribed MOUD for at least 14 days prior to hospitalization and are willing to start MOUD including buprenorphine will be randomized 1:1 to two different strategies. After baseline assessments are performed, eligible participants will be randomized in a 1:1 ratio to XR-BUP or TAU
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 9, 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
 Drug: Extended Release Buprenorphine
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 Name: Medication for Opioid Use Disorder
Active Comparator: Treatment as Usual
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.
 Drug: Treatment as Usual
Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
Other Name: Standard Medication for Opioid Use Disorder


Outcome Measures
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Primary Outcome Measures :
  1. 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.).


Secondary Outcome Measures :
  1. Proportion of participants that experience Adverse Events (AE) [ Time Frame: 34 days ]
    34-days following hospital discharge

  2. Proportion of participants engaged with MOUD [ Time Frame: Days 90 and 180 post hospital discharge ]
    90- and 180-days following hospital discharge

  3. 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

  4. Proportion of participants with self-reported opioid use [ Time Frame: Days 34, 90 and 180 post hospital discharge ]
  5. Self-reported 30- and 90-day hospital readmission rates [ Time Frame: Days 30 and 90 post hospital discharge ]
  6. Self-reported 30- and 90-day Emergency Department (ED) visit rates [ Time Frame: Days 30 and 90 post hospital discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hospitalized.
  2. At least 18 years of age.
  3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
  4. Willing to initiate MOUD, including buprenorphine.
  5. Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Anticipated length of stay less than 24-hours as determined by the ACS

  2. 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:

    1. Disabling terminal diagnosis for which discharge from hospital is not anticipated.
    2. Disabling terminal diagnosis for which hospice care is being sought.
    3. Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.
  3. 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.
  4. Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.
  5. Currently pregnant.
  6. Known allergy to buprenorphine or components of Atrigel delivery system.
  7. 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.
  8. 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.
  9. Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345718


Contacts
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Contact: Paulette A Baukol 612-873-6993 pbaukol@bermancenter.org
Contact: Rebecca Kent, MS 8155295495 rkent@bermancenter.org

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Jennifer Edelman, MD,MHS         
Principal Investigator: Jennifer Edelman, MD,MHS         
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Megan Buresh, MD         
Principal Investigator: Megan Buresh, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sarah Wakeman, MD         
Principal Investigator: Sarah Wakeman, MD         
Boston University Recruiting
Boston, Massachusetts, United States, 02118
Contact: Richard Saitz, MD,MPH         
Principal Investigator: Richard Saitz, MD,MPH         
United States, Minnesota
Hennepin Healthcare Research Institute Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Gavin Bart, MD,PhD         
Principal Investigator: Gavin Bart, MD,PhD         
Sponsors and Collaborators
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Investigators
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Principal Investigator: Gavin Bart, MD,PhD Hennepin Heatlhcare
More Information
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Publications:

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Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT04345718    
Other Study ID Numbers: NIDA CTN 0098A
5UG1DA040316-05 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: February 5, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
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.
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.
URL: https://datashare.nida.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hennepin Healthcare Research Institute:
MOUD
XR-BUP
ACS
OUD
SUD
Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic-Related Disorders
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists