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Clinical Decision Support to Improve System Naloxone Co-prescribing

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Trial completed Final enrollment: 114272 participants (planned 200000) · Study completion date changed from estimate of Oct 2026 to Apr 1, 2026 · Secondary endpoints: details revised at 1 of 3 entries · 1 more Show 4 more changesShow less
    • Final enrollment: 114272 participants (planned 200000)
    • Study completion date changed from estimate of Oct 2026 to Apr 1, 2026
    • Secondary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 5 words
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Completion date: Apr 2026 to Oct 2026v8 Show 1 more changeShow less
    • Completion date: Apr 2026 to Oct 2026
  4. Primary completion date changed from estimate of Oct 2025 to Oct 31, 2025v7
  5. Primary completion date: Oct 31, 2025 to Oct 2025 Completion date: May 1, 2026 to Apr 2026v6 Show 1 more changeShow less
    • Completion date: May 1, 2026 to Apr 2026
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jul 2025 to Oct 31, 2025 Completion date: Dec 2025 to May 1, 2026v5 Show 1 more changeShow less
    • Completion date: Dec 2025 to May 1, 2026
  2. Collaborators reorderedv4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary completion date: Mar 2026 to Jul 2025 · Completion date: Sep 2026 to Dec 2025 · Start date changed from estimate of Apr 2024 to Jul 1, 2024v3 Show 3 more changesShow less
    • Primary completion date: Mar 2026 to Jul 2025
    • Completion date: Sep 2026 to Dec 2025
    • Start date changed from estimate of Apr 2024 to Jul 1, 2024
  4. Interventions: Naloxone Co-prescribing CDS (Other) to Naloxone Co-prescribing Clinical Decision Support (CDS) (Other) Secondary endpoints revised (3) · Eligibility criteria expanded, about 3 wordsv2 Show 2 more changesShow less
    • Secondary endpoints revised (3)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06271668
Lead Sponsor University of Colorado, Denver
Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Conditions Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
Enrollment 114,272 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov