Medication AbuseNCT06527079
Evaluation of Clinical Decision Support in Opioid Tapering
An observational study of Medication Abuse and Harm Reduction, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 89 years
- Conditions the study is for
- Medication Abuse, Harm Reduction, Opioid Use Disorder
- What is being tested?
- Observational study without a prospective intervention
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing, Opioid Overdose, Prevention
- Being tested
- Observational study without a prospective intervention
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Opioid-Related Disorders, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study without a prospective interventionOther
observational study without a prospective intervention
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. Receives: Other: Observational study without a prospective intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of potential taper-benefit patients
The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial
Measured: 8 months
Secondary outcomes (2)
Observed tapering
The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly as an indication of tapering
Measured: 8 months
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AbuseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jason Hoppe, DO, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527079
- Sponsor's protocol ID
- 24-1193
- Other IDs
- 24-1193, R61DA057610
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Decision Support in Opioid Tapering
- ClinicalTrials.gov ID
- NCT06527079
- Acronym / sponsor ID
- 24-1193
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing, Opioid Overdose, Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | Other: Observational study without a prospective interventionControl group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study without a prospective interventionobservational study without a prospective intervention | Other | Usual Care |
Primary outcome
Percentage of potential taper-benefit patients
Time frame: 8 months
The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial
2 secondary outcomes
Observed tapering
Time frame: 8 months
Taper magnitude
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Medication Abuse
RecruitingObservational study
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
Medication Abuse, Harm Reduction
Not yet recruitingObservational study
Clinical Decision Support for Safety of Opioid Transitions
Medication Abuse, Harm Reduction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Hoppe, DO principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Abuse and Harm Reduction, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Tolle, PhD (303-724-9924, heather.tolle@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of potential taper-benefit patients (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.