Opioid Use DisorderHOTPIN-IFNCT07568847
Improving Hospital-To-Methadone Clinic Connection Using Implementation Support for Patients With Opioid Use Disorder
A study testing HOTPIN-IF in people with Opioid Use Disorder, run by University of Colorado, Denver.
Trial summary
The goal of this clinical trial is to learn if a hospital-based approach can help people with opioid use disorder (OUD) connect to a methadone clinic after leaving the hospital. This study focuses on adults with OUD who are in the hospital and want to start methadone treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- HOTPIN-IF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Nov 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Hospitalized with DSM-5 opioid use disorder, confirmed by clinical assessment
- Eligible for methadone treatment as determined by the clinical team
- Not currently enrolled in an Opioid Treatment Program (OTP)
- Anticipated discharge to the community
- Willing to initiate methadone and follow up at a partnering OTP
Who cannot join
- Current enrollment in an Opioid Treatment Program (OTP)
- Planned discharge to a correctional or institutional setting that precludes OTP follow-up
- Medical or psychiatric instability that precludes safe methadone initiation or completion of study procedures
- Inability to provide required information for OTP intake due to impaired cognition or altered mental status
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sarah Mann, MA contact
About this study
Official title: Facilitating In-Hospital Opioid Treatment Program Intakes to Support Hospital to OTP Linkage Among Hospitalized Patients With Opioid Use Disorder: An Implementation Trial in Four Hospitals
The goal of this clinical trial is to learn if a hospital-based approach can help people with opioid use disorder (OUD) connect to a methadone clinic after leaving the hospital. This study focuses on adults with OUD who are in the hospital and want to start methadone treatment. Methadone is a safe and effective treatment for OUD. It can reduce cravings, prevent withdrawal, and lower the risk of overdose and death. Even though methadone works well, many people do not receive it. For people who start treatment in the hospital, the time after discharge is a high-risk period. Many patients do not connect to a methadone clinic after they leave. This can lead to return to opioid use, overdose, repeat hospital visits, and poor health. This study tests a new approach where hospital teams help complete the methadone clinic intake during the hospital stay. This approach uses trained hospital staff and structured workflows to complete key parts of the intake process before discharge. The goal is to reduce delays and make it easier for patients to connect to care right after leaving the hospital. The main questions it aims to answer are: 1) Does completing a methadone clinic intake during the hospital stay increase the number of people who connect to a methadone clinic after discharge? 2) Does providing support to hospital teams increase how often these in-hospital intakes are completed? Researchers will compare usual hospital care (referral at discharge) to a hospital-based approach that helps complete methadone clinic intake during the hospital stay to see if this improves connection to care.
Read the detailed description
The purpose of this study is to test whether a hospital-based approach can improve connection to methadone treatment after discharge. The approach includes completing OTP intake during hospitalization and supporting hospital teams through an implementation strategy called implementation facilitation (IF). This study also aims to understand how well the approach can be adopted and sustained across different hospitals. This is a multi-site clinical trial conducted at four hospitals. The study uses a hybrid type 2 implementation-effectiveness design, meaning it evaluates both patient outcomes and how the intervention is implemented. The study uses an incomplete stepped wedge cluster randomized design. In this design:
- All hospitals begin in a usual care phase
- Hospitals are randomly assigned a time to switch to the intervention
- Over time, each hospital transitions from usual care to the intervention phase
- This allows each hospital to serve as its own comparison
During the usual care phase, patients receive standard care, which includes referral to an OTP at discharge. During the intervention phase, hospital teams receive implementation support to help complete OTP intake during the hospital stay. The intervention is an implementation strategy designed to support hospital teams in completing OTP intake during hospitalization.
The study uses the RE-AIM framework to evaluate outcomes:
- Reach: The number and characteristics of patients who complete OTP intake and connect to care.
- Effectiveness: The primary outcome is connection to an OTP after hospital discharge (for example, within 7 days). Secondary outcomes may include engagement in treatment at 30 and 90 days, healthcare use, and mortality.
- Adoption: The proportion of hospital clinicians and teams who use the new workflows and complete OTP intake.
- Implementation: How well the intervention is delivered, including fidelity to core components, adaptations, and resources used.
- Maintenance: Whether the intervention is sustained over time after initial implementation.
The study will also assess implementation costs and identify barriers and facilitators to adoption.
Participants are adults with OUD who are hospitalized and interested in starting methadone treatment. Participants must be willing to connect to a methadone clinic after discharge.
Data will be collected from multiple sources, including:
- Electronic health records (EHRs) from participating hospitals
- Data from opioid treatment programs (when available)
- Study questionnaires completed during enrollment
- Administrative data on healthcare use
- National Death Index data for mortality outcomes
- Data will be combined across sites using a structured data approach to ensure consistency.
The analysis will evaluate:
- Differences in OTP connection rates
- Changes in treatment engagement over time
- Variation across hospitals
- Implementation outcomes and costs
- Qualitative data from interviews and observations may also be used to understand how the intervention works in real-world settings.
This study addresses a major gap in care for people with OUD. Improving connection to methadone treatment after hospitalization has the potential to reduce overdose deaths, improve health outcomes, and reduce healthcare use. By testing both effectiveness and implementation, this study will provide practical information for scaling this approach across hospitals.
If successful, this model could be widely adopted to improve access to life-saving treatment for people with OUD.
- Conditions
- Opioid Use Disorder
- Being tested
- HOTPIN-IF
- Keywords
- implementation facilitation, hospital based care, opioid use disorder, methadone, opioid treatment program
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOTPIN-IFBehavioural
Participants receive care at sites after rollout of Implementation Facilitation (IF) to support HOTPIN workflows.
Focus on completing in-hospital OTP intake, including:
Medical assessment Screening labs Methadone initiation Transportation coordination
Supported by:
External facilitators Learning collaboratives Workflow integration into the EHR
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Standard hospital-to-OTP referral processes without implementation facilitation Receives: Behavioral: HOTPIN-IF |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Hospital-to-OTP Linkage
The primary outcome is whether a participant successfully connects to an Opioid Treatment Program (OTP) within 7 days after hospital discharge. Connection" (linkage) is defined as:
Completion of OTP intake and/or attendance at the OTP, and Receipt or continuation of methadone treatment at the OTP
Measured: Measured within 7 days following hospital discharge
Secondary outcomes (2)
30-Day OTP Engagement
Description:
Proportion of participants who remain engaged in methadone treatment at an Opioid Treatment Program (OTP) within 30 days after hospital discharge.
Defined by ongoing dosing or documented attendance at the OTP Reflects short-term treatment retention
Measured: 30 days after hospital discharge
90-Day OTP Engagement (Retention)
Description:
Proportion of participants who remain engaged in methadone treatment at an OTP within 90 days after hospital discharge.
Defined by continued dosing records or clinic attendance Reflects longer-term treatment retention
Measured: Within 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Susan L Calcaterra, MD, MPH, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568847
- Sponsor's protocol ID
- 26-0455
- Other IDs
- 1R01DA063733-01A1
- Acronym
- HOTPIN-IF
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data (IPD) using a controlled access process (not open download) We will require: Data Use Agreement (DUA) IRB approval or exemption data security plan We will exclude: Direct identifiers Anything restricted under 42 CFR Part 2 without proper authorization
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating In-Hospital Opioid Treatment Program Intakes to Support Hospital to OTP Linkage Among Hospitalized Patients With Opioid Use Disorder: An Implementation Trial in Four Hospitals
- ClinicalTrials.gov ID
- NCT07568847
- Acronym / sponsor ID
- HOTPIN-IF / 26-0455
- Conditions
- Opioid Use Disorder
- Keywords
- implementation facilitation, hospital based care, opioid use disorder, methadone, opioid treatment program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 6 May 2026 (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.
The goal of this clinical trial is to learn if a hospital-based approach can help people with opioid use disorder (OUD) connect to a methadone clinic after leaving the hospital. This study focuses on adults with OUD who are in the hospital and want to start methadone treatment. Methadone is a safe and effective treatment for OUD. It can reduce cravings, prevent withdrawal, and lower the risk of overdose and death. Even though methadone works well, many people do not receive it. For people who start treatment in the hospital, the time after discharge is a high-risk period. Many patients do not connect to a methadone clinic after they leave. This can lead to return to opioid use, overdose, repeat hospital visits, and poor health. This study tests a new approach where hospital teams help complete the methadone clinic intake during the hospital stay. This approach uses trained hospital staff and structured workflows to complete key parts of the intake process before discharge. The goal is to reduce delays and make it easier for patients to connect to care right after leaving the hospital. The main questions it aims to answer are: 1) Does completing a methadone clinic intake during the hospital stay increase the number of people who connect to a methadone clinic after discharge? 2) Does providing support to hospital teams increase how often these in-hospital intakes are completed? Researchers will compare usual hospital care (referral at discharge) to a hospital-based approach that helps complete methadone clinic intake during the hospital stay to see if this improves connection to care.
Detailed description
The purpose of this study is to test whether a hospital-based approach can improve connection to methadone treatment after discharge. The approach includes completing OTP intake during hospitalization and supporting hospital teams through an implementation strategy called implementation facilitation (IF). This study also aims to understand how well the approach can be adopted and sustained across different hospitals. This is a multi-site clinical trial conducted at four hospitals. The study uses a hybrid type 2 implementation-effectiveness design, meaning it evaluates both patient outcomes and how the intervention is implemented. The study uses an incomplete stepped wedge cluster randomized design. In this design:
- All hospitals begin in a usual care phase
- Hospitals are randomly assigned a time to switch to the intervention
- Over time, each hospital transitions from usual care to the intervention phase
- This allows each hospital to serve as its own comparison
During the usual care phase, patients receive standard care, which includes referral to an OTP at discharge. During the intervention phase, hospital teams receive implementation support to help complete OTP intake during the hospital stay. The intervention is an implementation strategy designed to support hospital teams in completing OTP intake during hospitalization.
The study uses the RE-AIM framework to evaluate outcomes:
- Reach: The number and characteristics of patients who complete OTP intake and connect to care.
- Effectiveness: The primary outcome is connection to an OTP after hospital discharge (for example, within 7 days). Secondary outcomes may include engagement in treatment at 30 and 90 days, healthcare use, and mortality.
- Adoption: The proportion of hospital clinicians and teams who use the new workflows and complete OTP intake.
- Implementation: How well the intervention is delivered, including fidelity to core components, adaptations, and resources used.
- Maintenance: Whether the intervention is sustained over time after initial implementation.
The study will also assess implementation costs and identify barriers and facilitators to adoption.
Participants are adults with OUD who are hospitalized and interested in starting methadone treatment. Participants must be willing to connect to a methadone clinic after discharge.
Data will be collected from multiple sources, including:
- Electronic health records (EHRs) from participating hospitals
- Data from opioid treatment programs (when available)
- Study questionnaires completed during enrollment
- Administrative data on healthcare use
- National Death Index data for mortality outcomes
- Data will be combined across sites using a structured data approach to ensure consistency.
The analysis will evaluate:
- Differences in OTP connection rates
- Changes in treatment engagement over time
- Variation across hospitals
- Implementation outcomes and costs
- Qualitative data from interviews and observations may also be used to understand how the intervention works in real-world settings.
This study addresses a major gap in care for people with OUD. Improving connection to methadone treatment after hospitalization has the potential to reduce overdose deaths, improve health outcomes, and reduce healthcare use. By testing both effectiveness and implementation, this study will provide practical information for scaling this approach across hospitals.
If successful, this model could be widely adopted to improve access to life-saving treatment for people with OUD.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: HOTPIN-IFStandard hospital-to-OTP referral processes without implementation facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Hospitalized with DSM-5 opioid use disorder, confirmed by clinical assessment
- Eligible for methadone treatment as determined by the clinical team
- Not currently enrolled in an Opioid Treatment Program (OTP)
- Anticipated discharge to the community
Key exclusion criteria (4 listed)
- Current enrollment in an Opioid Treatment Program (OTP)
- Planned discharge to a correctional or institutional setting that precludes OTP follow-up
- Medical or psychiatric instability that precludes safe methadone initiation or completion of study procedures
- Inability to provide required information for OTP intake due to impaired cognition or altered mental status
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 |
|---|---|---|
| HOTPIN-IFParticipants receive care at sites after rollout of Implementation Facilitation (IF) to support HOTPIN workflows. Focus on completing in-hospital OTP intake, including: Medical assessment Screening labs Methadone initiation Transportation coordination Supported by: External facilitators Learning collaboratives Workflow integration into the EHR | Behavioural | Usual Care |
Primary outcome
7-Day Hospital-to-OTP Linkage
Time frame: Measured within 7 days following hospital discharge
The primary outcome is whether a participant successfully connects to an Opioid Treatment Program (OTP) within 7 days after hospital discharge. Connection" (linkage) is defined as: Completion of OTP intake and/or attendance at the OTP, and Receipt or continuation of methadone treatment at the OTP
2 secondary outcomes
30-Day OTP Engagement
Time frame: 30 days after hospital discharge
90-Day OTP Engagement (Retention)
Time frame: Within 90 days after hospital discharge
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 18 May 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified individual participant data (IPD) using a controlled access process (not open download) We will require: Data Use Agreement (DUA) IRB approval or exemption data security plan We will exclude: Direct identifiers Anything restricted under 42 CFR Part 2 without proper authorization
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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.
Sarah Mann, MA contact
Susan L Calcaterra, MD, MPH, MS principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing HOTPIN-IF in people with Opioid Use Disorder, run by University of Colorado, Denver.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Susan L Calcaterra, MD, MPH, MS (2487035947, susan.calcaterra@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Hospital-to-OTP Linkage (time frame: Measured within 7 days following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.