ClinicalTrials.gg
RecruitingNCT06526286Updated Sep 21, 2026

Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder

An observational study in Medication Abuse, Harm Reduction and Opioid Use Disorder, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 12 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Primary conditionOpioid-Related DisordersRegistry: Substance-Related DisordersReclassifiedWhy we changed it
Registry
Substance-Related Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Opioid-Related Disorders
Why
  1. The study's listed conditions name Opioid-Related Disorders, a narrower term within Substance-Related Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200,000
Ages
12 Years to 89 Years
Sex
All
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Study 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.

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Conditions studied

  • Medication Abuse
  • Harm Reduction
  • Opioid Use Disorder
  • Supportive Care

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03

In context

Opioid-Related Disorders Reclassified

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 200,000 is above the median of 129 across 184 observational studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Compared within Opioid-Related Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Substance-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Active cancer diagnosis in the last 1 year
  • Hospice care/palliative care order
  • Sickle cell disease diagnosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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

Interventions

  • OtherMedications 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. Subsequent opioid overdose/poisoning rates

    The number of patients who had a diagnosis of opioid overdose or poisoning

    Time frame: Six months after an encounter where the opioid use disorder is identified

  3. Buprenorphine initiation

    Number of patients who filled a buprenorphine prescription after being identified at risk.

    Time frame: Six months after an encounter where the opioid use disorder is identified

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Time frame: Data will be provided to National Addiction and HIV Data Archive Program (NAHDAP) after study results are published in peer-reviewed journals.

Access criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement

Data sharing details ↗ · www.icpsr.umich.edu

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06526286
Responsible party
Sponsor
First posted
Jul 29, 2024
Start date
Jul 7, 2026
Primary completion
Jan 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Heather Tolle, PhD
Contact
heather.tolle@cuanschutz.edu
303-724-9924
Jason Hoppe, DO
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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