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EXHIT ENTRE Comparative Effectiveness Trial (EXHITENTRE)

Primary Purpose

Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Extended Release Buprenorphine

Treatment as Usual

About this trial

This is an interventional treatment trial for Substance Use Disorder focused on measuring MOUD, XR-BUP, ACS, OUD, SUD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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.
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.

Sites / Locations

Yale New Haven HospitalRecruiting
Johns Hopkins Bayview Medical CenterRecruiting
Massachusetts General HospitalRecruiting
Boston UniversityRecruiting
Hennepin Healthcare Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional

Treatment as Usual

Arm Description

Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.

Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.

Outcomes

Primary Outcome Measures

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.).

Secondary Outcome Measures

Proportion of participants that experience Adverse Events (AE)

34-days following hospital discharge

Proportion of participants engaged with MOUD

90- and 180-days following hospital discharge

Proportion of participants with positive urine drug test

for illicit opioids 34-, and 90-, and 180-days following hospital discharge

Proportion of participants with self-reported opioid use

Self-reported 30- and 90-day hospital readmission rates

Self-reported 30- and 90-day Emergency Department (ED) visit rates

Full Information

NCT ID

NCT04345718

First Posted

April 9, 2020

Last Updated

April 19, 2023

Sponsor

Hennepin Healthcare Research Institute

Collaborators

National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04345718

Brief Title

EXHIT ENTRE Comparative Effectiveness Trial

Acronym

EXHITENTRE

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 9, 2021 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hennepin Healthcare Research Institute

Collaborators

National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe

Keywords

MOUD, XR-BUP, ACS, OUD, SUD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional

Arm Type

Experimental

Arm Description

Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.

Arm Title

Treatment as Usual

Arm Type

Active Comparator

Arm Description

Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.

Intervention Type

Drug

Intervention Name(s)

Extended Release Buprenorphine

Other Intervention Name(s)

Medication for Opioid Use Disorder

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Treatment as Usual

Other Intervention Name(s)

Standard Medication for Opioid Use Disorder

Intervention Description

Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.

Primary Outcome Measure Information:

Title

The proportion of participants engaged in OUD care on the 34th day following hospital discharge.

Description

Time Frame

34 days post discharge from hospital

Secondary Outcome Measure Information:

Title

Proportion of participants that experience Adverse Events (AE)

Description

34-days following hospital discharge

Time Frame

34 days

Title

Proportion of participants engaged with MOUD

Description

90- and 180-days following hospital discharge

Time Frame

Days 90 and 180 post hospital discharge

Title

Proportion of participants with positive urine drug test

Description

for illicit opioids 34-, and 90-, and 180-days following hospital discharge

Time Frame

Days 34, 90 and 180 post hospital discharge

Title

Proportion of participants with self-reported opioid use

Time Frame

Days 34, 90 and 180 post hospital discharge

Title

Self-reported 30- and 90-day hospital readmission rates

Time Frame

Days 30 and 90 post hospital discharge

Title

Self-reported 30- and 90-day Emergency Department (ED) visit rates

Time Frame

Days 30 and 90 post hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paulette A Baukol

Phone

612-873-6993

pbaukol@bermancenter.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jayati Vohra, PT, MS

Phone

6124269433

jvohra@bermancenter.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gavin Bart, MD,PhD

Organizational Affiliation

Hennepin Heatlhcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Edelman, MD,MHS

First Name & Middle Initial & Last Name & Degree

Jennifer Edelman, MD,MHS

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megan Buresh, MD

First Name & Middle Initial & Last Name & Degree

Megan Buresh, MD

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Wakeman, MD

First Name & Middle Initial & Last Name & Degree

Sarah Wakeman, MD

Facility Name

Boston University

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Saitz, MD,MPH

First Name & Middle Initial & Last Name & Degree

Richard Saitz, MD,MPH

Facility Name

Hennepin Healthcare Research Institute

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gavin Bart, MD,PhD

First Name & Middle Initial & Last Name & Degree

Gavin Bart, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://datashare.nida.nih.gov/

Citations:

PubMed Identifier

25090173

Citation

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.

Results Reference

background

PubMed Identifier

29799968

Citation

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.

Results Reference

background

PubMed Identifier

28673521

Citation

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.

Results Reference

background

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EXHIT ENTRE Comparative Effectiveness Trial

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