Substance Use DisordersEXHITENTRENCT04921787
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
A study testing Low Intensity and High Intensity in people with Substance Use Disorders and Opioid Use Disorder, Severe, run by Gavin Bart at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Use Disorders, Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
- What is being tested?
- Low Intensity and High Intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Oct 2021to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
- Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
- 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.
- Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
- Be willing to be randomized to low-intensity or high-intensity implementation support.
- Provide inpatient general medical care.
- 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.
Who cannot join
- Have an ACS routinely prescribing MOUD at discharge.
- Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
- Be a Veterans Affairs hospital.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston University
Boston, Massachusetts, 02119
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55404
New York University
New York, New York, 10016
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Low Intensity, High Intensity
- Keywords
- HBOT, MOUD, OUD, SUD, OTP, ED
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low IntensityOther
Also called Training and education
Training and education only, a low-intensity strategy inclusive of an HBOT manual, one-time live training on how to use the HBOT manual, and 7 video conference presentations.
High IntensityOther
Also called Practice Facilitation
Practice facilitation, a high-intensity strategy inclusive of low-intensity training, plus practice facilitation that is based in part on a program planning model. This study is a hybrid implementation effectiveness design, testing an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity | Active comparator | MOUD training and support through the use of educational materials. Receives: Other: Low Intensity |
| High Intensity | Experimental | MOUD training and support through the use of educational materials in addition to practice facilitation. Receives: Other: High Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 34 days following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start22 Oct 2021
- Primary completion21 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This 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. Approximately 24 hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD, 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gavin Bart
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Gavin Bart, Hennepin Healthcare Research Institute
- Investigators
- Gavin Bart, MD,PhD, Principal investigator, Hennepin Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921787
- Sponsor's protocol ID
- NIDA CTN 0098B
- Other IDs
- 2UG1DA040316-06
- Acronym
- EXHITENTRE
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28673521Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
PubMed 25889199Bart G, Korthuis PT, Donohue JM, Hagedorn HJ, Gustafson DH, Bazzi AR, Enns E, McNeely J, Ghitza UE, Magane KM, Baukol P, Vena A, Harris J, Voronca D, Saitz R. Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder. Addict Sci Clin Pract. 2024 Apr 11;19(1):29. doi: 10.1186/s13722-024-00455-9.
PubMed 38600571
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04921787
- Acronym / sponsor ID
- EXHITENTRE / NIDA CTN 0098B
- Keywords
- HBOT, MOUD, OUD, SUD, OTP, ED
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gavin BartUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This 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. Approximately 24 hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD, 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.
| Arm | Type | Receives |
|---|---|---|
| Low Intensity | Active comparator | Other: Low IntensityMOUD training and support through the use of educational materials. |
| High Intensity | Experimental | Other: High IntensityMOUD training and support through the use of educational materials in addition to practice facilitation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
- Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
- 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.
- Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
Key exclusion criteria (3 listed)
- Have an ACS routinely prescribing MOUD at discharge.
- Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
- Be a Veterans Affairs hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low IntensityAlso: Training and educationTraining and education only, a low-intensity strategy inclusive of an HBOT manual, one-time live training on how to use the HBOT manual, and 7 video conference presentations. | Other | Low Intensity |
| High IntensityAlso: Practice FacilitationPractice facilitation, a high-intensity strategy inclusive of low-intensity training, plus practice facilitation that is based in part on a program planning model. This study is a hybrid implementation effectiveness design, testing an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. | Other | High Intensity |
Primary outcome
Engagement with MOUD
Time frame: 34 days following hospital discharge
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 28673521Trowbridge 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.
- Background: PubMed 20957426Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
- Background: PubMed 25889199Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- Derived from this study: PubMed 38600571Bart G, Korthuis PT, Donohue JM, Hagedorn HJ, Gustafson DH, Bazzi AR, Enns E, McNeely J, Ghitza UE, Magane KM, Baukol P, Vena A, Harris J, Voronca D, Saitz R. Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder. Addict Sci Clin Pract. 2024 Apr 11;19(1):29. doi: 10.1186/s13722-024-00455-9.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Bart, MD,PhD principal investigator
Hennepin Healthcare
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity and High Intensity in people with Substance Use Disorders and Opioid Use Disorder, Severe, run by Gavin Bart at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with MOUD (time frame: 34 days following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04921787, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.