An observational study in Medication Abuse, Harm Reduction and Opioid Overdose, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 12 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Colorado, Denver · Observational
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.
Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 114,272 is above the median of 284 across 16 observational studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →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 Opiate Overdose, 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 →
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) 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.
Exclusion Criteria:
Encounters where the naloxone clinical decision support (CDS) alert fired. CDS logic is programmed to fire alert when a provider places and order for a high-risk opioid analgesic prescription to a patient without an active naloxone prescription. High-risk prescription logic to trigger the Naloxone CDS: \[(NOT 1 AND (2 AND AT LEAST 1 OF (3, 4, 5, 6))) AND 7 AND NOT 8\] 1. ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER 2. OPIOID SCRIPT BEING PLACED CRITERIA 3. DAILY Milligram Morphine Equivalent (MME) \>=90 UNSIGNED ORDER 4. DAILY MME \>=90 EXISTING 5. DIAGNOSIS OF OPIOID USE DISORDER 6. DIAGNOSIS HISTORY OF OPIOID OVERDOSE 7. PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS 8. DISCHARGE TO HOSPICE
Other: Naloxone Co-prescribing Clinical Decision Support (CDS)
Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care.
Clinical decision support in the form of an EHR-integrated, provider facing alert suggesting (a) the opioid medication order is considered high risk for overdose and (b) to nudge providers to add a naloxone prescription to the opioid prescription to mitigate risk in the event of an overdose.
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
The number of high-risk opioid encounters where a naloxone prescription was written with the opioid divided by the total number of encounters where a high-risk opioid prescription was written.
Time frame: 18 months
Clinical decision support (CDS) acceptance rate
The number of times providers accepted the Clinical decision support (CDS) suggestion and co-prescribed naloxone with a high-risk opioid divided by the total number of times a high-risk opioid prescription triggered the CDS alert.
Time frame: 18 months
Subsequent opioid overdose/poisonings rates
The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following the index visit with a high-risk opioid prescribed.
Time frame: Six months after an encounter where the naloxone clinical decision support fired for the provider
Naloxone dispensed rate
The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.
Time frame: In the 3 days after the naloxone prescription is written
Plan to share: Yes — De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
Supporting information: Study protocol
Time frame: Data will be provided to 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.
Ran from Jul 2024 to primary completion in Oct 2025, 15 months.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Apr 2026, on Sep 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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