EXHITENTRE: EXHIT ENTRE Comparative Effectiveness Trial

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04345718

Collaborator

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

314

Enrollment

Locations

Arms

37.7

Anticipated Duration (Months)

62.8

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated Enrollment :

314 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 TAUThis 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 :

Aug 9, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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 Names: 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 Names: Standard Medication for Opioid Use Disorder

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 Names:

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 Names:

Standard Medication for Opioid Use Disorder

Outcome Measures

Primary Outcome Measures

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

Proportion of participants that experience Adverse Events (AE) [34 days]
34-days following hospital discharge
Proportion of participants engaged with MOUD [Days 90 and 180 post hospital discharge]
90- and 180-days following hospital discharge
Proportion of participants with positive urine drug test [Days 34, 90 and 180 post hospital discharge]
for illicit opioids 34-, and 90-, and 180-days following hospital discharge
Proportion of participants with self-reported opioid use [Days 34, 90 and 180 post hospital discharge]
Self-reported 30- and 90-day hospital readmission rates [Days 30 and 90 post hospital discharge]
Self-reported 30- and 90-day Emergency Department (ED) visit rates [Days 30 and 90 post hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Hennepin Healthcare Research Institute	Minneapolis	Minnesota	United States	55404