Opioid MisuseNCT05182606

Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy

A study testing Pilot study of algorithms implementation package in people with Opioid Misuse and Chronic Pain, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid Misuse, Chronic Pain
What is being tested?: Pilot study of algorithms implementation package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2022to 30 Sep 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Clinicians practicing at UPMC community primary care clinics.

Who cannot join

Clinicians not practicing at UPMC community primary care clinics.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15231

Other trials in United States

About this study

Official title: Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy: Developing Implementation Strategies and Pilot Testing

The NIH Helping to End Addiction Long-term (HEAL) initiative has identified a critical next step to addressing the opioid crisis: improving treatments for opioid misuse behaviors (e.g., using more opioids than prescribed, illicit substance use) in patients prescribed long-term opioid therapy for chronic pain. In previous work, the investigators have developed innovative consensus-based algorithms to manage these behaviors. By developing implementation strategies for these algorithms, this project is directly responsive to the HEAL initiative and promises to reduce opioid misuse-related harms.

Read the detailed description

Despite a growing understanding of the risks of long-term opioid therapy (LTOT), it continues to be frequently prescribed and remains a mainstay of treatment for chronic pain. The Centers for Disease and Control (CDC) Guideline for Prescribing Opioids for Chronic Pain is geared toward primary care providers and has been adopted as the standard of care by many healthcare organizations and insurers. Importantly, it encourages monitoring of patients on LTOT for opioid-related harms. By implementing monitoring, primary care providers may uncover various concerning behaviors, sometimes called aberrant drug-related behaviors or opioid misuse behaviors, that arise among individuals prescribed LTOT for chronic pain. These behaviors (e.g., missed appointments, using more opioid medication than prescribed, asking for an increase in opioid dose, aggressive behavior, and alcohol and other substance use) are common, concerning, and may represent unsafe use of LTOT or a developing opioid use disorder (OUD). However, the CDC Guideline and other existing evidence do not provide specific, detailed guidance about how to address concerning behaviors when they occur. Therefore, there is a critical need to understand how to best respond to these behaviors. The long-term goal of our program of research is to reduce LTOT-related harms, particularly from opioid misuse, and diminish their impact on the U.S. opioid epidemic. As a first step toward accomplishing this goal, the investigators conducted a Delphi study to rigorously establish consensus-based approaches to managing common and challenging concerning behaviors, from which algorithms were created. Identifying and operationalizing implementation strategies using an evidence-based framework are the critical next steps that must occur before any testing of the algorithms.

The investigators successfully uncovered optimal implementation strategies through primary care provider experiences with Standardized Patients (SPs) followed by Consolidated Framework for Implementation Research (CFIR)- and Expert Recommendations for Implementing Change (ERIC)-guided individual interviews. Using our prior expertise developing clinic-wide opioid risk reduction strategies and a Patient-Provider advisory board, the investigators developed a comprehensive "implementation package" that can be delivered to primary care practices.

The investigators now aim to conduct a pilot trial to test the algorithm implementation package. Guided by the CFIR-based implementation plan and using the implementation package that the investigators developed, pilot trial will be conducted to investigate feasibility, acceptability, and preliminary effectiveness of the algorithm implementation package.

Conditions: Opioid Misuse, Chronic Pain
Being tested: Pilot study of algorithms implementation package
Keywords: Long-Term Opioid Therapy, Algorithms, Opioid Misuse, Chronic Pain
Medical subject headings: Opioid-Related Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pilot study of algorithms implementation packageBehavioural
The algorithm implementation package includes a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.

Study groups in NCT05182606
Study group	Role	What they receive
Implementation Bundle	Experimental	The 'Implementation Bundle' was integrated into all three participating clinics over six to nine months. Receives: Behavioral: Pilot study of algorithms implementation package

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Algorithms
The number of algorithms used by physicians was assessed via a survey administered at the end of the 6- or 9-month implementation period, measuring self-reported toolkit utilization during the study. Our primary feasibility benchmark will be that 80% of physicians report using at least one algorithm during the study period.
Measured: At the end of the 6- or 9-month implementation period
Acceptability of Algorithms
Acceptability of the algorithms was assessed via a self-report survey administered at the end of the 6- or 9-month implementation period, measuring physicians' awareness of the algorithms and self-reported toolkit use within six months of implementation. Our primary acceptability benchmark is that at least 80% of physicians report awareness of the algorithm implementation and at least 50% report using the algorithms during the study period. Additionally, qualitative interviews with physicians and staff provided further insights, which were analyzed using thematic analysis.
Measured: At the end of the 6- or 9-month implementation period

Secondary outcomes (4)

Preliminary Effectiveness of Algorithms - MME Reduction ≥10%
Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) decreased at or above a margin of 10% from the start of the reporting period to the end of the reporting period.
Measured: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)
Preliminary Effectiveness - Average MME Within Last 90 Days
Average morphine milligram equivalents (MME) among long-term opioid therapy (LTOT) patients during the last 90 days of each period.
Measured: Pre-implementation (12 months), implementation (6 or 9 months), post-implementation (12 months)
Preliminary Effectiveness of Algorithms - Opioid Discontinuation
Number of long-term opioid therapy (LTOT) patients whose 90-day average Morphine Milligram Equivalents (MME) at the start of this reporting period was 0.
Measured: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)
Preliminary Effectiveness of the Algorithms - New OUD Diagnoses in LTOT Patients
New opioid use disorder (OUD) diagnoses documented in the electronic health record (EHR) among all LTOT patients seen by participating physicians, by period. No new OUD diagnoses were documented in any period in LTOT patients.
Measured: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202230 Sep 2024

First posted10 Jan 2022
Study start1 Mar 2022
Primary completion30 Sep 2023
Study completion30 Sep 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 Opioid MisuseStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Model description: Investigators will conduct a pilot trial to assess the feasibility, acceptability, and preliminary effectiveness of the Algorithm Implementation Package across three University of Pittsburgh Medical Center (UPMC) primary care practices. The intervention will be implemented using a staggered rollout across the three clinics - General Internal Medicine Oakland will receive the intervention first, followed by Northern Medical Associates Hampton and Wexford. All clinics will receive the same intervention. Feasibility and acceptability will be assessed once only after the 6- or 9-month implementation period through clinician surveys and qualitative interviews. Preliminary effectiveness will be evaluated using electronic health record (EHR) data assessing reductions in concerning opioid-related behaviors and increases in the diagnosis and treatment of Opioid Use Disorder.
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05182606
Sponsor's protocol ID: STUDY20030189
Other IDs: R34DA050004
Status last verified: Jun 2026
First submitted: 28 Nov 2021
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Misuse trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Consensus-based Algorithms to Address Opioid Misuse Behaviors Among Individuals Prescribed Long-term Opioid Therapy: Developing Implementation Strategies and Pilot Testing
ClinicalTrials.gov ID: NCT05182606
Acronym / sponsor ID: STUDY20030189
Conditions: Opioid Misuse, Chronic Pain
Keywords: Long-Term Opioid Therapy, Algorithms, Opioid Misuse, Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Mar 2022 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 10 Jan 2022 (actual)
Results: Posted 18 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Investigators will conduct a pilot trial to assess the feasibility, acceptability, and preliminary effectiveness of the Algorithm Implementation Package across three University of Pittsburgh Medical Center (UPMC) primary care practices. The intervention will be implemented using a staggered rollout across the three clinics - General Internal Medicine Oakland will receive the intervention first, followed by Northern Medical Associates Hampton and Wexford. All clinics will receive the same intervention. Feasibility and acceptability will be assessed once only after the 6- or 9-month implementation period through clinician surveys and qualitative interviews. Preliminary effectiveness will be evaluated using electronic health record (EHR) data assessing reductions in concerning opioid-related behaviors and increases in the diagnosis and treatment of Opioid Use Disorder.

Arm	Type	Receives
Implementation Bundle	Experimental	Behavioral: Pilot study of algorithms implementation packageThe 'Implementation Bundle' was integrated into all three participating clinics over six to nine months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Clinicians practicing at UPMC community primary care clinics.

Key exclusion criteria (1 listed)

Clinicians not practicing at UPMC community primary care clinics.

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
Pilot study of algorithms implementation packageThe algorithm implementation package includes a link to the algorithms in the Electronic Health Record, Smartphrases, audited feedback, and instructions.	Behavioural	Implementation Bundle

Primary outcome

Feasibility of Algorithms
Time frame: At the end of the 6- or 9-month implementation period
The number of algorithms used by physicians was assessed via a survey administered at the end of the 6- or 9-month implementation period, measuring self-reported toolkit utilization during the study. Our primary feasibility benchmark will be that 80% of physicians report using at least one algorithm during the study period.
Acceptability of Algorithms
Time frame: At the end of the 6- or 9-month implementation period
Acceptability of the algorithms was assessed via a self-report survey administered at the end of the 6- or 9-month implementation period, measuring physicians' awareness of the algorithms and self-reported toolkit use within six months of implementation. Our primary acceptability benchmark is that at least 80% of physicians report awareness of the algorithm implementation and at least 50% report using the algorithms during the study period. Additionally, qualitative interviews with physicians and staff provided further insights, which were analyzed using thematic analysis.

4 secondary outcomes

Preliminary Effectiveness of Algorithms - MME Reduction ≥10%
Time frame: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)
Preliminary Effectiveness - Average MME Within Last 90 Days
Time frame: Pre-implementation (12 months), implementation (6 or 9 months), post-implementation (12 months)
Preliminary Effectiveness of Algorithms - Opioid Discontinuation
Time frame: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)
Preliminary Effectiveness of the Algorithms - New OUD Diagnoses in LTOT Patients
Time frame: Pre-implementation (12 months), implementation (6 to 9 months), post-implementation (12 months)

Results and safety

Results posted to the registry on 18 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implementation Bundle	49	49

Primary outcome: Feasibility of Algorithms

Time frame: At the end of the 6- or 9-month implementation period. Count of participants. Unit: Participants

Measure	Implementation Bundle n = 20
Physicians who used at least one algorithm	7
Physicians who did not use any algorithm or did not respond to this question	13

Population analysed: Physicians from the three participating clinics who agreed to participate in the post-implementation survey.

Primary outcome: Acceptability of Algorithms

Time frame: At the end of the 6- or 9-month implementation period. Count of participants. Unit: Participants

Measure	Implementation Bundle n = 20
Physicians aware of algorithm implementation	19
Physicians who used at least one algorithm	7

Population analysed: Physicians from the three participating clinics who agreed to participate in post-implementation surveys.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months for the academic clinic, 21 months for the two community clinics. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implementation	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Post-implementation	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): The study's findings are limited by its pilot nature, focusing on a small number of clinics and clinicians. Results may not be generalizable to other settings or populations. Additionally, qualitative data were collected from a subset of participants, which may not fully represent all perspectives. The limited follow-up time may also restrict the interpretation of longer-term outcomes or broader feasibility.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Jessica Merlin principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pilot study of algorithms implementation package in people with Opioid Misuse and Chronic Pain, run by University of Pittsburgh 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 30 Jun 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 18 Jun 2025). 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?

Feasibility of Algorithms (time frame: At the end of the 6- or 9-month implementation period). 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?

On the ClinicalTrials.gov record for NCT05182606.

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 Jun 2026.