Opioid Use DisorderNCT06291090
A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision
A study testing OUD treatment intervention in people with Opioid Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- OUD treatment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medicl Campus
Aurora, Colorado, 80045
About this study
Official title: In Hospital Treatment of Opioid Use Disorder: Clinician Perspectives and Current Practices
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.
Read the detailed description
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. The intervention included nurse driven universal screening for unhealthy substance use with a social work referral for a brief intervention when indicted, electronic health record-embedded protocols to assess for opioid withdrawal and to direct buprenorphine initiation, methadone orders for opioid withdrawal symptoms, and embedded links for post discharge addiction treatment referral. It also included clinician education and nursing education via video conference or in-person lectures. The intervention was supported by the health system Chief Medical Officer and involved subject matters expertise and representation from nursing leaders, social work leaders, and hospital medicine leaders. Outcomes assess include a pre/post implementation assessment of 1) change in buprenorphine prescribed in hospital and 2) discharge, 3) change in naloxone prescribed, 4) change in hospital based methadone prescribing, and 5) change in average clinical opioid withdrawal scale (COWS) score. investigators also assessed a pre/post survey of hospitalists physicians and advanced practice providers to assess their perception of hospital based OUD treatment provision.
- Conditions
- Opioid Use Disorder
- Being tested
- OUD treatment intervention
- Keywords
- opioid use disorder, hospital
- 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.
OUD treatment interventionBehavioural
Participants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge.
| Study group | Role | What they receive |
|---|---|---|
| OUD intervention | Experimental | Participants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge. Receives: Behavioral: OUD treatment intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in buprenorphine prescribing at hospital discharge
Change in rate of buprenorphine prescribing at hospital discharge among patients with OUD before and after intervention implementation
Measured: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
Secondary outcomes (1)
Change in rates of methadone prescribing during hospitalization
Change in rate of in hospital methadone prescribing among patients with OUD before and after intervention implementation
Measured: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start18 Jan 2023
- Primary completion30 Apr 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single group
- Model description
- This intervention will be implemented across 12 hospitals
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
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, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291090
- Sponsor's protocol ID
- 22-0789
- Other IDs
- K08DA049905
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calcaterra SL, Lockhart S, Natvig C, Mikulich-Gilbertson SK. Measuring the Impact of a Multi-Site In-Hospital Intervention for Opioid Use Disorder Treatment Provision: A Survey of Hospital-Based Clinicians. J Gen Intern Med. 2026 Mar;41(4):1048-1057. doi: 10.1007/s11606-025-09728-8. Epub 2025 Aug 27.
PubMed 40866748Calcaterra SL, Lockhart S, Grimm E, Holtrop JS, Keniston A, Hoppe JA, Lebin JA, Binswanger IA. A mixed methods assessment of an electronic health record-embedded intervention with supportive education and outreach to increase in-hospital opioid use disorder treatment initiation. J Hosp Med. 2026 Feb 19:10.1002/jhm.70289. doi: 10.1002/jhm.70289. Online ahead of print.
PubMed 41715987Calcaterra SL, Lockhart S, Natvig C, Mikulich S. Barriers to initiate buprenorphine and methadone for opioid use disorder treatment with postdischarge treatment linkage. J Hosp Med. 2023 Oct;18(10):896-907. doi: 10.1002/jhm.13193. Epub 2023 Aug 22.
PubMed 37608527
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Hospital Treatment of Opioid Use Disorder: Clinician Perspectives and Current Practices
- ClinicalTrials.gov ID
- NCT06291090
- Acronym / sponsor ID
- 22-0789
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 Mar 2024 (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 investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.
Detailed description
The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. The intervention included nurse driven universal screening for unhealthy substance use with a social work referral for a brief intervention when indicted, electronic health record-embedded protocols to assess for opioid withdrawal and to direct buprenorphine initiation, methadone orders for opioid withdrawal symptoms, and embedded links for post discharge addiction treatment referral. It also included clinician education and nursing education via video conference or in-person lectures. The intervention was supported by the health system Chief Medical Officer and involved subject matters expertise and representation from nursing leaders, social work leaders, and hospital medicine leaders. Outcomes assess include a pre/post implementation assessment of 1) change in buprenorphine prescribed in hospital and 2) discharge, 3) change in naloxone prescribed, 4) change in hospital based methadone prescribing, and 5) change in average clinical opioid withdrawal scale (COWS) score. investigators also assessed a pre/post survey of hospitalists physicians and advanced practice providers to assess their perception of hospital based OUD treatment provision.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This intervention will be implemented across 12 hospitals
| Arm | Type | Receives |
|---|---|---|
| OUD intervention | Experimental | Behavioral: OUD treatment interventionParticipants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| OUD treatment interventionParticipants received education on the diagnosis and management of OUD, have access to protocols to walk them through assessment of OUD using Diagnostic and Statistical Manual, fifth Edition (DSM)-5, COWS score to calculate severity of opioid withdrawal, buprenorphine or methadone initiation with pre-populated orders, and clickable links for OUD treatment referral post discharge. | Behavioural | OUD intervention |
Primary outcome
Change in buprenorphine prescribing at hospital discharge
Time frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
Change in rate of buprenorphine prescribing at hospital discharge among patients with OUD before and after intervention implementation
1 secondary outcome
Change in rates of methadone prescribing during hospitalization
Time frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Results publication: PubMed 40866748Calcaterra SL, Lockhart S, Natvig C, Mikulich-Gilbertson SK. Measuring the Impact of a Multi-Site In-Hospital Intervention for Opioid Use Disorder Treatment Provision: A Survey of Hospital-Based Clinicians. J Gen Intern Med. 2026 Mar;41(4):1048-1057. doi: 10.1007/s11606-025-09728-8. Epub 2025 Aug 27.
- Results publication: PubMed 41715987Calcaterra SL, Lockhart S, Grimm E, Holtrop JS, Keniston A, Hoppe JA, Lebin JA, Binswanger IA. A mixed methods assessment of an electronic health record-embedded intervention with supportive education and outreach to increase in-hospital opioid use disorder treatment initiation. J Hosp Med. 2026 Feb 19:10.1002/jhm.70289. doi: 10.1002/jhm.70289. Online ahead of print.
- Results publication: PubMed 37608527Calcaterra SL, Lockhart S, Natvig C, Mikulich S. Barriers to initiate buprenorphine and methadone for opioid use disorder treatment with postdischarge treatment linkage. J Hosp Med. 2023 Oct;18(10):896-907. doi: 10.1002/jhm.13193. Epub 2023 Aug 22.
- Individual participant dataSharing planned: No
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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.
Susan L Calcaterra, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OUD treatment intervention in people with Opioid Use Disorder, run by University of Colorado, Denver at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in buprenorphine prescribing at hospital discharge (time frame: Calculate monthly prescribing rates over a three year time frame (including pre and post implementation) to assess for change). 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 NCT06291090, which also lists 3 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 1 May 2026.