ClinicalTrials.gg
Not yet recruitingNCT06527079Updated Sep 30, 2026

Evaluation of Clinical Decision Support in Opioid Tapering

An observational study in Medication Abuse, Harm Reduction and Opioid Use Disorder, sponsored by University of Colorado, Denver. Not yet recruiting. Open to participants aged 12 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Primary conditionOpiate OverdoseRegistry: Substance-Related DisordersReclassifiedWhy we changed it
Registry
Substance-Related Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Opiate Overdose
Why
  1. The study's listed conditions name Opiate Overdose, 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

Updated Sep 30, 2026Start date movedPrimary completion moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200,000
Ages
12 Years to 89 Years
Sex
All
01

Study summary

The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will examine the state of tapering in primary care across the system as well as conduct stakeholder interviews to understand the resources available across the system to support providers in tapering and identify opportunities for clinical decision support to be implemented to support guideline concordant tapering. Utilization of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering will be examined. The rate of opioid tapering in line with CDC guidelines will be examined as well as long term patient outcomes of opioid overdose of poisoning using existing patient health records. The study period will be approximately 8 months.

02

Conditions studied

  • Medication Abuse
  • Harm Reduction
  • Opioid Use Disorder
  • Opioid Prescribing
  • Opioid Overdose
  • Prevention
03

In context

Opiate Overdose Reclassified

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's planned enrollment of 200,000 is above the median of 284 across 16 observational studies indexed under Opiate Overdose.

Browse Opiate Overdose 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 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 →

04

Who can participate

Ages eligible
12 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
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 receiving long-term opioid treatment.

Eligibility criteria

Inclusion Criteria: Primary care patients being tapered from an opioid. Tapering patients:

  • Have an active opioid prescription for more than 3 months and
  • Prescribed more than 90 morphine milligram equivalents (MME) per day or
  • Co-prescribed an opioid and benzodiazepine or
  • Received a reduction in opioid dosage by more than 5% MME per day

Exclusion Criteria:

  • Patients \<12 and >89
  • Patients with active cancer diagnosis in last 1 year
  • Patients with hospice care/palliative care order
  • Patients with sickle cell disease diagnosis
05

Study design

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

Groups and cohorts

  • Usual Care

    Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.

    Other: Observational study without a prospective intervention

Interventions

  • OtherObservational study without a prospective intervention

    observational study without a prospective intervention

06

What researchers measure

Primary outcomes

  1. Percentage of potential taper-benefit patients

    The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial

    Time frame: 8 months

Secondary outcomes

  1. Observed tapering

    The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly as an indication of tapering

    Time frame: 8 months

  2. Taper magnitude

    The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly at a rate in line with guideline recommendations

    Time frame: 8 months

07

Study locations

No study locations are listed for this record.

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) repository after final study results have been published.

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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: start Aug 2026 → Nov 2026 and primary completion Dec 2026 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 30, 2024
StartEst.
Nov 2026was Aug 2026
Primary completionEst.
Mar 2027was Dec 2026
CompletionEst.
Jun 2027
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 2026→Nov 2026
Sep 30, 2026
Primary completion
Dec 2026→Mar 2027
Sep 30, 2026
Eligibility
Revised
Sep 30, 2026
Interventions
Added Observational study without a prospective intervention; removed Opioid Tapering Pathway Clinical Decision Support (CDS). Arms removed: CDS Notification
Sep 30, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Percentage of encounters tapering within CDC guidelinesNow Percentage of potential taper-benefit patientsTime frame: 18 months → 8 months
Sep 30, 2026
Secondary outcomes
2 added, 3 removed
What changed in the outcomes
  • AddedObserved taperingTime frame: 8 months
  • AddedTaper magnitudeTime frame: 8 months
  • RemovedClinical decision support (CDS) acceptance rateTime frame: 18 months
  • RemovedSubsequent opioid overdose/poisoning ratesTime frame: 6 months after taper encounter
  • RemovedHealth care utilizationTime frame: 6 months after taper encounter
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Start date Aug 2026→Nov 2026
    Primary completion Dec 2026→Mar 2027
    Eligibility Revised
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Percentage of encounters tapering within CDC guidelinesNow Percentage of potential taper-benefit patientsTime frame: 18 months → 8 months
    Secondary outcomes 2 added, 3 removed
    What changed in the outcomes
    • AddedObserved taperingTime frame: 8 months
    • AddedTaper magnitudeTime frame: 8 months
    • RemovedClinical decision support (CDS) acceptance rateTime frame: 18 months
    • RemovedSubsequent opioid overdose/poisoning ratesTime frame: 6 months after taper encounter
    • RemovedHealth care utilizationTime frame: 6 months after taper encounter
    Interventions Added Observational study without a prospective intervention; removed Opioid Tapering Pathway Clinical Decision Support (CDS). Arms removed: CDS Notification
    + 4 other changes: index terms, verification date, description and design details

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 ↗

10

Registry details

Key details

Study ID
NCT06527079
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Nov 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 30, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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