Medication AbuseNCT06526286
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
An observational study of Medication Abuse and Harm Reduction, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. Read more about this study
- Who is it for?
- Ages 12 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Abuse, Harm Reduction, Opioid Use Disorder
- What is being tested?
- Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to May 2027
- Phase
- Observational
- 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 12 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system.
Who may be able to join
- Primary care encounter AND
- Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
- Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
- Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
- Is taking >=90 morphine milligram equivalents (MME) per day OR
- Prior positive toxicology screen for illicit drugs OR
- Diagnosis of opioid use disorder
Who cannot join
- Active cancer diagnosis in the last 1 year
- Hospice care/palliative care order
- Sickle cell disease diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCHealth
Aurora, Colorado, 80045
Heather Tolle, 720-848-6777, heather.tolle@cuanschutz.edu
About this study
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will implement a passive CDS alert when a provider prescribes an opioid to a patient who may be at risk of opioid use disorder. Providers will also have link access to a clinical care pathway providing support for OUD screening and treatment. Before and after comparisons of buprenorphine (a medication used to treat opioid use disorder) prescribing by providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Supportive Care
- Being tested
- Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)Other
Clinical decision support (CDS) in the form of an electronic health record (EHR)-integrated, provider-facing notification suggesting (a) the patient may be at risk for opioid use disorder and could benefit from screening, (b) patients with opioid use disorder would benefit from treatment with buprenorphine and (c) utilization of a clinical care pathway to help treat patients with opioid use disorder with buprenorphine as suggested by the Center for Disease Control and Prevention (CDC) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| pre implementation period | Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. | |
| CDS Notification | Providers will see a clinical decision support tool within the electronic health record when treating a patient at risk for opioid use disorder to encourage the provider to use a clinical care pathway to assess for opioid use disorder and when applicable, treat opioid use disorder with buprenorphine. Smart text will also be available in the electronic health record so that the provider can easily document screening and treatment discussions with the patient. Receives: Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder
The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria
Measured: 18 months
Secondary outcomes (3)
Clinical decision support (CDS) acceptance rate
The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway in treating opioid use disorder.
Measured: 18 months
Subsequent opioid overdose/poisoning rates
The number of patients who had a diagnosis of opioid overdose or poisoning
Measured: Six months after an encounter where the opioid use disorder is identified
Buprenorphine initiation
Number of patients who filled a buprenorphine prescription after being identified at risk.
Measured: Six months after an encounter where the opioid use disorder is identified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AbuseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jason Hoppe, DO, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526286
- Sponsor's protocol ID
- 24-1188
- Other IDs
- 24-1188, R61DA057610
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) after results of the study are published.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06526286
- Acronym / sponsor ID
- 24-1188
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Supportive Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Jul 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 objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will implement a passive CDS alert when a provider prescribes an opioid to a patient who may be at risk of opioid use disorder. Providers will also have link access to a clinical care pathway providing support for OUD screening and treatment. Before and after comparisons of buprenorphine (a medication used to treat opioid use disorder) prescribing by providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre implementation period | – | –Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. |
| CDS Notification | – | Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)Providers will see a clinical decision support tool within the electronic health record when treating a patient at risk for opioid use disorder to encourage the provider to use a clinical care pathway to assess for opioid use disorder and when applicable, treat opioid use disorder with buprenorphine. Smart text will also be available in the electronic health record so that the provider can easily document screening and treatment discussions with the patient. |
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system.
Key inclusion criteria (7 listed)
- Primary care encounter AND
- Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
- Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
- Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
- Is taking >=90 morphine milligram equivalents (MME) per day OR
Key exclusion criteria (3 listed)
- Active cancer diagnosis in the last 1 year
- Hospice care/palliative care order
- Sickle cell disease diagnosis
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 |
|---|---|---|
| Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)Clinical decision support (CDS) in the form of an electronic health record (EHR)-integrated, provider-facing notification suggesting (a) the patient may be at risk for opioid use disorder and could benefit from screening, (b) patients with opioid use disorder would benefit from treatment with buprenorphine and (c) utilization of a clinical care pathway to help treat patients with opioid use disorder with buprenorphine as suggested by the Center for Disease Control and Prevention (CDC) guidelines. | Other | CDS Notification |
Primary outcome
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder
Time frame: 18 months
The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria
3 secondary outcomes
Clinical decision support (CDS) acceptance rate
Time frame: 18 months
Subsequent opioid overdose/poisoning rates
Time frame: Six months after an encounter where the opioid use disorder is identified
Buprenorphine initiation
Time frame: Six months after an encounter where the opioid use disorder is identified
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) after results of the study are published.
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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.
Jason Hoppe, DO 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?
An observational study of Medication Abuse and Harm Reduction, 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 7 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?
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 Heather Tolle, PhD (303-724-9924, heather.tolle@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder (time frame: 18 months). 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 21 Sep 2026.