Recruiting

OUD with MOUD

Sponsor:

University of Colorado, Denver

Code:

NCT06526286

Conditions

Medication Abuse

Harm Reduction

Opioid Use Disorder

Supportive Care

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Interventions

Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)

Study Details

Brief 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. 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

Study ID

NCT06526286

Start date

Jul 7, 2026

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active cancer diagnosis in the last 1 year
  • Hospice care/palliative care order
  • Sickle cell disease diagnosis

Study Design

Enrollment

200000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Heather Tolle, PhD

303-724-9924heather.tolle@cuanschutz.edu

Locations

UCHealth

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Heather Tolle

720-848-6777heather.tolle@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.