Opioid AbusePHARMSCREENNCT03936985
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
An observational study of Opioid Abuse and Prescription Drug Abuse (Not Dependent), run by University of Utah at 2 sites in United States.
Trial summary
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse, Prescription Drug Abuse (Not Dependent)
- How many people
- 1,464 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2019to 31 May 2023
- Phase
- Observational
- 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
Study population: Adults 18 years or older, prescribed opioid medications from one of 15 participating pharmacies.
Who may be able to join
- be dispensed ≥1 opioid medication (including tramadol) by a participating pharmacy;
- be ≥18 years of age according to pharmacy data and self-report
Who cannot join
- solely filling buprenorphine or buprenorphine combination products i.e., patients receiving OUD treatment with no other opioid medication use;
- currently receiving treatment for cancer;
- having previously completed the survey;
- having current involvement with the criminal justice system that has, or could, lead to incarceration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267
University of Utah
Salt Lake City, Utah, 84108
About this study
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard instrument that defines patient risk levels. No intervention or hypothesis will be tested.
Read the detailed description
Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids has continued to increase across the US-continuing to increase in 35 states from 2013-2017. Given these persistent trends for adverse opioid-related outcomes in populations across the US, it is critical to work to identify those who are at risk, deliver appropriate care that will help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to those who suffer from opioid use disorder. Therefore, it is necessary to expand the continuum of care to health care settings that previously may have been underutilized. One underutilized resource for addressing the current opioid epidemic is community pharmacies.The most important clinical tool pharmacists have available to identify possible misuse of opioid medications is prescription drug monitoring programs (PDMP),which capture patient-level prescription dispensing information to inform monitoring, dispensing decisions, and possible intervention.These tools are available in all US states and have the potential to enable pharmacists to identify patients at-risk for opioid-related adverse events, such as addiction and overdose. In light of the continued escalation of the opioid epidemic nationally, combined with the promising opportunities afforded by the further inclusion of community pharmacy settings for engaging patients with opioid-related risk, it is important to evaluate whether current PDMP risk metrics correlate with clinically validated opioid risk tools and if clinically meaningful risk cutoffs exist for PDMP risk metrics.
This study will evaluate the concurrent validity of a PDMP-based opioid risk metric as a clinical measure of high risk opioid use and establish clinically useful risk-level thresholds relative to the widely validated gold standard of the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST). This study is a one group, cross-sectional, health assessment study. Participants who enroll in the study will complete on-line surveys at a single time point. Approximately 1,523 patients will be recruited from approximately 15 community community pharmacies. Trained pharmacy staff will inform potentially eligible participants, or individuals receiving at least one prescription(s) for potentially eligible participants, of the survey opportunity. Patients recruited will complete validated measures to assess opioid use and risk behaviors, substance use, and physical and mental health. A series of a priori analyses will be conducted to evaluate the validity of the PDMP-based opioid risk metric relative to the widely validated gold standard WHO ASSIST and to identify cutoff thresholds. Correlational, regression, and Cohen's Kappa statistical analyses will also be conducted to evaluate the relationship between the risk metric and the WHO ASSIST.
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the PDMP Narcotic Score Versus the WHO ASSIST
To assess the validity of the PDMP Narcotic Score, the AUC (Area Under the Curve) was used. AUC ranges in value from 0 to 1. A model whose predictions are 100% wrong has an AUC of 0.0; one whose predictions are 100% correct has an AUC of 1.0. And when AUC is 0.5, it means the model has no means of separating between the different groups. For this study, the closer to 1.0 the more similar the PDMP Narcotic Score is to the WHO ASSIST.
Measured: The ASSIST was administered once at Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start4 Nov 2019
- Primary completion30 Aug 2021
- Study completion31 May 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, Purdue University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jerry Cochran, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936985
- Sponsor's protocol ID
- CTN-0093
- Other IDs
- 5UG1DA049444
- Acronym
- PHARMSCREEN
- Status last verified
- Jul 2024
- First submitted
- 30 Apr 2019
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charron E, Brooks JH, Peterson KT, Akinwolere OG, Winhusen T, Cochran G. Mapping prescription drug monitoring program data to self-report measures of non-medical prescription opioid use in community pharmacy settings. Res Social Adm Pharm. 2023 Aug;19(8):1171-1177. doi: 10.1016/j.sapharm.2023.04.121. Epub 2023 Apr 23.
PubMed 37142474Charron E, Okifuji A, Bryan MA, Reese S, Brown JL, Ferguson A, Ghitza UE, Winhusen T, Cochran G. Pain Severity and Interference and Substance Use Among Community Pharmacy Patients Prescribed Opioids: A Secondary Analysis of the PHARMSCREEN Study. J Pain. 2022 Aug;23(8):1448-1459. doi: 10.1016/j.jpain.2022.03.238. Epub 2022 Apr 11.
PubMed 35417791
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
- ClinicalTrials.gov ID
- NCT03936985
- Acronym / sponsor ID
- PHARMSCREEN / CTN-0093
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,464 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Cincinnati, Purdue University, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard instrument that defines patient risk levels. No intervention or hypothesis will be tested.
Detailed description
Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids has continued to increase across the US-continuing to increase in 35 states from 2013-2017. Given these persistent trends for adverse opioid-related outcomes in populations across the US, it is critical to work to identify those who are at risk, deliver appropriate care that will help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to those who suffer from opioid use disorder. Therefore, it is necessary to expand the continuum of care to health care settings that previously may have been underutilized. One underutilized resource for addressing the current opioid epidemic is community pharmacies.The most important clinical tool pharmacists have available to identify possible misuse of opioid medications is prescription drug monitoring programs (PDMP),which capture patient-level prescription dispensing information to inform monitoring, dispensing decisions, and possible intervention.These tools are available in all US states and have the potential to enable pharmacists to identify patients at-risk for opioid-related adverse events, such as addiction and overdose. In light of the continued escalation of the opioid epidemic nationally, combined with the promising opportunities afforded by the further inclusion of community pharmacy settings for engaging patients with opioid-related risk, it is important to evaluate whether current PDMP risk metrics correlate with clinically validated opioid risk tools and if clinically meaningful risk cutoffs exist for PDMP risk metrics.
This study will evaluate the concurrent validity of a PDMP-based opioid risk metric as a clinical measure of high risk opioid use and establish clinically useful risk-level thresholds relative to the widely validated gold standard of the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST). This study is a one group, cross-sectional, health assessment study. Participants who enroll in the study will complete on-line surveys at a single time point. Approximately 1,523 patients will be recruited from approximately 15 community community pharmacies. Trained pharmacy staff will inform potentially eligible participants, or individuals receiving at least one prescription(s) for potentially eligible participants, of the survey opportunity. Patients recruited will complete validated measures to assess opioid use and risk behaviors, substance use, and physical and mental health. A series of a priori analyses will be conducted to evaluate the validity of the PDMP-based opioid risk metric relative to the widely validated gold standard WHO ASSIST and to identify cutoff thresholds. Correlational, regression, and Cohen's Kappa statistical analyses will also be conducted to evaluate the relationship between the risk metric and the WHO ASSIST.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years or older, prescribed opioid medications from one of 15 participating pharmacies.
Key inclusion criteria (2 listed)
- be dispensed ≥1 opioid medication (including tramadol) by a participating pharmacy;
- be ≥18 years of age according to pharmacy data and self-report
Key exclusion criteria (4 listed)
- solely filling buprenorphine or buprenorphine combination products i.e., patients receiving OUD treatment with no other opioid medication use;
- currently receiving treatment for cancer;
- having previously completed the survey;
- having current involvement with the criminal justice system that has, or could, lead to incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of the PDMP Narcotic Score Versus the WHO ASSIST
Time frame: The ASSIST was administered once at Day 1.
To assess the validity of the PDMP Narcotic Score, the AUC (Area Under the Curve) was used. AUC ranges in value from 0 to 1. A model whose predictions are 100% wrong has an AUC of 0.0; one whose predictions are 100% correct has an AUC of 1.0. And when AUC is 0.5, it means the model has no means of separating between the different groups. For this study, the closer to 1.0 the more similar the PDMP Narcotic Score is to the WHO ASSIST.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37142474Charron E, Brooks JH, Peterson KT, Akinwolere OG, Winhusen T, Cochran G. Mapping prescription drug monitoring program data to self-report measures of non-medical prescription opioid use in community pharmacy settings. Res Social Adm Pharm. 2023 Aug;19(8):1171-1177. doi: 10.1016/j.sapharm.2023.04.121. Epub 2023 Apr 23.
- Derived from this study: PubMed 35417791Charron E, Okifuji A, Bryan MA, Reese S, Brown JL, Ferguson A, Ghitza UE, Winhusen T, Cochran G. Pain Severity and Interference and Substance Use Among Community Pharmacy Patients Prescribed Opioids: A Secondary Analysis of the PHARMSCREEN Study. J Pain. 2022 Aug;23(8):1448-1459. doi: 10.1016/j.jpain.2022.03.238. Epub 2022 Apr 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Abuse and Prescription Drug Abuse (Not Dependent), run by University of Utah at 2 sites 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 2 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: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 11 Jul 2024). 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?
Validity of the PDMP Narcotic Score Versus the WHO ASSIST (time frame: The ASSIST was administered once at Day 1.). 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 NCT03936985, which also lists 2 linked publications.
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 11 Jul 2024.