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EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy | Clinical Trials | Clareo Health

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EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Implementation Trial of High Intensity Versus Low Intensity Strategy for Supporting Hospital-Based Opioid Use Disorder Treatment

NCT04921787•Gavin Bart

View on ClinicalTrials.gov

Summary

This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.

Detailed Description

The study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD. Community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub. Participants will be assessed for "engagement with MOUD", measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. Further outcomes will be assessed during the entire 4-year study period.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data.
•2. Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
•3. Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
•4. Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine.
•5. Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
•6. Be willing to be randomized to low-intensity or high-intensity implementation support.
•7. Provide inpatient general medical care.
•8. Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge.

Exclusion Criteria

•1. Have an ACS routinely prescribing MOUD at discharge.
•2. Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
•3. Be a Veterans Affairs hospital.

Locations (4)

Boston University

Boston, Massachusetts, United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

New York University

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

October 22, 2021

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2026

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Substance Use DisordersOpioid Use Disorder, SevereOpioid Use Disorder, Moderate

Interventions

Low Intensity

OTHER

High Intensity

OTHER

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

NCT04197921

Opioid-use DisorderSubstance Use Disorders

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RECRUITINGPHASE2

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

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Opioid Use DisorderOpioid Use Disorder, Moderate+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy

Inclusion Criteria

Exclusion Criteria

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

Temporal Interference Methods for Addiction Treatment

Improving Social Functioning in People With Substance Use and Mental Health Disorders Using VR

Enhancing Prospective Thinking in Early Recovery

Home Treatment for Individuals Suffering From Severe Addictive Disorders