PainNCT05808127
Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
A study testing PainTracker and Current Opioid Misuse Measure in people with Pain and Opioid Use, run by University of Southern California at 1 site in United States.
Trial summary
Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain, Opioid Use
- What is being tested?
- PainTracker and Current Opioid Misuse Measure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 9 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.
Who cannot join
- Patient visits with active cancer diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.
The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 286 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=1451).
Read the detailed description
Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the patient sample. Clinicians treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure [COMM] [standard clinical care] or 2) COMM + PainTracker. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.
- Conditions
- Pain, Opioid Use
- Being tested
- PainTracker, Current Opioid Misuse Measure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainTrackerBehavioural
The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.
Current Opioid Misuse MeasureBehavioural
The abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.
| Study group | Role | What they receive |
|---|---|---|
| Current Opioid Misuse Measure (COMM) | Active comparator | On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale. Receives: Behavioral: Current Opioid Misuse Measure |
| Current Opioid Misuse Measure (COMM) + PainTracker | Experimental | On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety. Receives: Behavioral: PainTracker; Behavioral: Current Opioid Misuse Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Referrals to Non-opioid Care
Count of referrals to non-opioid care during the timeframe of 8/9/2023-5/8/2024. Referrals to non-opioid care include mental and behavioral health care, physical therapy, and/or sleep medicine referrals
Measured: 9 months
Count of Antidepressant Orders
Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
Measured: 9 months
Secondary outcomes (2)
Clinician Monthly Milligram Morphine Equivalent (MME)
The statistic reported represents the interaction of differences between the pre and post periods. Using data from the electronic health record, we estimated total monthly milligram morphine equivalent for each clinician summing the total number of daily morphine equivalents written within a monthly observation period. That outcome is observed repeatedly over time. The monthly values are not separate outcomes; they are repeated measurements of the same quantity. The scientific question is whether the intervention changes the linear trajectory of the outcome relative to control. The analysis summarizes this change into a single, prespecified effect rather than comparing months one by one.
MME standardizes the potency of different opioid medications into a single value based on morphine, providing a comparable measure for which to evaluate intervention impact.
Measured: 9 months
Benzodiazepine Prescribing
The statistic reported represents the interaction of differences between the pre and post periods. Using data from the electronic health record, we estimated total monthly milligram valium equivalent for each clinician summing the total number of daily valium equivalents written within a monthly observation period. That outcome is observed repeatedly over time. The monthly values are not separate outcomes; they are repeated measurements of the same quantity. The scientific question is whether the intervention changes the linear trajectory of the outcome relative to control. The analysis summarizes this change into a single, prespecified effect rather than comparing months one by one.
VE standardizes the potency of different benzodiazepine medications into a single value based on valium, providing a comparable measure for which to evaluate intervention impact.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start9 Aug 2023
- Primary completion9 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinicians treating Chronic Opioid Use Registry patients will be randomized to one of two conditions involving surveys completed by the patients: (1) Current Opioid Misuse Measure \[COMM\] \[standard clinical care\] or (2) COMM + PainTracker
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institute on Aging (NIA), University of Washington
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Jason Doctor, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808127
- Sponsor's protocol ID
- HS-22-00517
- Other IDs
- 3P30AG024968-20S1
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2023
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
- ClinicalTrials.gov ID
- NCT05808127
- Acronym / sponsor ID
- HS-22-00517
- Conditions
- Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute on Aging (NIA), University of Washington
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.
The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 286 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=1451).
Detailed description
Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the patient sample. Clinicians treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure [COMM] [standard clinical care] or 2) COMM + PainTracker. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Clinicians treating Chronic Opioid Use Registry patients will be randomized to one of two conditions involving surveys completed by the patients: (1) Current Opioid Misuse Measure [COMM] [standard clinical care] or (2) COMM + PainTracker
| Arm | Type | Receives |
|---|---|---|
| Current Opioid Misuse Measure (COMM) | Active comparator | Behavioral: Current Opioid Misuse MeasureOn a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale. |
| Current Opioid Misuse Measure (COMM) + PainTracker | Experimental | Behavioral: PainTracker, Behavioral: Current Opioid Misuse MeasureOn a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.
Key exclusion criteria (1 listed)
- Patient visits with active cancer diagnoses
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 |
|---|---|---|
| PainTrackerThe PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up. | Behavioural | Current Opioid Misuse Measure (COMM) + PainTracker |
| Current Opioid Misuse MeasureThe abbreviated Current Opioid Misuse Measure (COMM) is a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale. | Behavioural | Current Opioid Misuse Measure (COMM), Current Opioid Misuse Measure (COMM) + PainTracker |
Primary outcome
Count of Referrals to Non-opioid Care
Time frame: 9 months
Count of referrals to non-opioid care during the timeframe of 8/9/2023-5/8/2024. Referrals to non-opioid care include mental and behavioral health care, physical therapy, and/or sleep medicine referrals
Count of Antidepressant Orders
Time frame: 9 months
Count of orders for antidepressant medications during the timeframe of 8/9/2023-5/8/2024.
2 secondary outcomes
Clinician Monthly Milligram Morphine Equivalent (MME)
Time frame: 9 months
Benzodiazepine Prescribing
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Jason Doctor, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PainTracker and Current Opioid Misuse Measure in people with Pain and Opioid Use, run by University of Southern California at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Referrals to Non-opioid Care (time frame: 9 months). The study lists 2 primary outcomes in all. 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 13 Apr 2026.