Opioid AbusePharmToolNCT05706311
Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool
A study testing Clinical Decision Support Tool (Moderate Risk) and Clinical Decision Support Tool (High Risk) in people with Opioid Abuse and Prescription Opioid Abuse, run by University of Utah at 2 sites in United States.
Trial summary
This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse, Prescription Opioid Abuse
- What is being tested?
- Clinical Decision Support Tool (Moderate Risk) and Clinical Decision Support Tool (High Risk)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2025to Aug 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A large chain retail pharmacy chain in the Cincinnati or Columbus, Ohio area
Who cannot join
- None
- This study does not involve individual patients as randomization will occur among pharmacies.
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
Official title: Adaption and Implementation of a Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool (PharmTool)
This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Once the Opioid Risk Reduction has been developed, we will examine the impact of the ORRCDS within two divisions of a large chain retail pharmacy. Pharmacies will be randomized to using the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool or standard of care opioid dispensation. We hypothesize that patients at pharmacies randomized to the ORRCDS tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.
Read the detailed description
In our previous research, patients have reported a willingness to answer questions and discuss opioid medication use with pharmacists in these settings. Therefore, community pharmacy settings are an underused resource with great promise for screening and engaging patients to reduce opioid medication misuse. Currently, prescription drug monitoring programs (PDMP) are the most available tool to pharmacists for monitoring opioid use among patients. As a result, PDMP users must rely on their "best judgment" in clinical decision-making and often provide patient care and referrals with a limited evidence base. The question of highest importance in the field of prescription medication misuse is: How can PDMP information/output be most usefully utilized for patient intervention within an evidence-based opioid risk reduction clinical decision support (ORRCDS) tool.
This study will develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool and examining facilitators and barriers to sustainability and broader dissemination. The study is organized into 3 aims:
Aim 1: ORRCDS Tool development which will include a universal opioid medication risk screener and decision support platform.
Aim 2: Once the ORRCDS has been developed, we will conduct a type-1 cluster 2-arm randomized trial to examine the impact of the ORRCDS tool within two divisions of a large chain retail pharmacy. We hypothesize that patients with moderate or high opioid risk will be more likely to reduce risk status to low or moderate following ORRCDS implementation compared to standard care.
Aim 3: Following the completion of the cluster randomized trial, qualitative interviews will be conducted with pharmacists and leaders from a large chain retail pharmacy and PDMP vendor about the potential barriers and facilitators to the sustainability (continued use at the stores in this project) and broader dissemination (implementation at other stores outside of those in this project) of the ORRCDS.
- Conditions
- Opioid Abuse, Prescription Opioid Abuse
- Being tested
- Clinical Decision Support Tool (Moderate Risk), Clinical Decision Support Tool (High Risk), Standard of Care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support Tool (Moderate Risk)Behavioural
Moderate risk patients will get brief motivational intervention for medication misuse and an offer of naloxone dispensation.
Clinical Decision Support Tool (High Risk)Behavioural
Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation.
Standard of CareOther
Ohio State law requires pharmacist to not dispense an opioid supply >90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Pharmacy Site | Experimental | Pharmacies randomized to the experimental arm will be exposed to the intervention condition.
Patients at the intervention pharmacy identified as at elevated risk will receive confirmatory screening for opioid risk. Those with confirmed moderate risk will receive a brief motivational intervention for medication misuse and an offer of naloxone dispensation. Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation. Receives: Behavioral: Clinical Decision Support Tool (Moderate Risk); Behavioral: Clinical Decision Support Tool (High Risk) |
| Control Pharmacy Site | Other | Standard of Care is the treatment as usual condition, which follows federal and Ohio state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Ohio State law requires pharmacist to not dispense an opioid supply >90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool
This outcome will be assessed using the System Usability Scale (SUS).
Measured: 24 months
Stage 2: Improvement in patient opioid-related risks
This outcome will be assessed using the Narcotic Score (NS).
Measured: 24 months
Stage 3: ORRCDS sustainability within the system and pharmacy chain systems
Using the Consolidated Framework for Implementation Research the investigators will interview staff from the PDMP vendor and large chain retail pharmacy to assesses the barriers of tool sustainability.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start21 Jan 2025
- Primary completion22 Jun 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a type-1 cluster 2-arm randomized trial. Randomization will take place at the pharmacy level and will be stratified by zip code level of poverty and pharmacy patient volume.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jerry Cochran, University of Utah
- Investigators
- Jerry Cochran, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706311
- Sponsor's protocol ID
- CTN-0138
- Other IDs
- 3UG1DA049444-04S2
- Acronym
- PharmTool
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaption and Implementation of a Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool (PharmTool)
- ClinicalTrials.gov ID
- NCT05706311
- Acronym / sponsor ID
- PharmTool / CTN-0138
- Conditions
- Opioid Abuse, Prescription Opioid Abuse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Cincinnati, National Institute on Drug Abuse (NIDA)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 22 Jun 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 31 Jan 2023 (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.
This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Once the Opioid Risk Reduction has been developed, we will examine the impact of the ORRCDS within two divisions of a large chain retail pharmacy. Pharmacies will be randomized to using the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool or standard of care opioid dispensation. We hypothesize that patients at pharmacies randomized to the ORRCDS tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.
Detailed description
In our previous research, patients have reported a willingness to answer questions and discuss opioid medication use with pharmacists in these settings. Therefore, community pharmacy settings are an underused resource with great promise for screening and engaging patients to reduce opioid medication misuse. Currently, prescription drug monitoring programs (PDMP) are the most available tool to pharmacists for monitoring opioid use among patients. As a result, PDMP users must rely on their "best judgment" in clinical decision-making and often provide patient care and referrals with a limited evidence base. The question of highest importance in the field of prescription medication misuse is: How can PDMP information/output be most usefully utilized for patient intervention within an evidence-based opioid risk reduction clinical decision support (ORRCDS) tool.
This study will develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool and examining facilitators and barriers to sustainability and broader dissemination. The study is organized into 3 aims:
Aim 1: ORRCDS Tool development which will include a universal opioid medication risk screener and decision support platform.
Aim 2: Once the ORRCDS has been developed, we will conduct a type-1 cluster 2-arm randomized trial to examine the impact of the ORRCDS tool within two divisions of a large chain retail pharmacy. We hypothesize that patients with moderate or high opioid risk will be more likely to reduce risk status to low or moderate following ORRCDS implementation compared to standard care.
Aim 3: Following the completion of the cluster randomized trial, qualitative interviews will be conducted with pharmacists and leaders from a large chain retail pharmacy and PDMP vendor about the potential barriers and facilitators to the sustainability (continued use at the stores in this project) and broader dissemination (implementation at other stores outside of those in this project) of the ORRCDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a type-1 cluster 2-arm randomized trial. Randomization will take place at the pharmacy level and will be stratified by zip code level of poverty and pharmacy patient volume.
| Arm | Type | Receives |
|---|---|---|
| Intervention Pharmacy Site | Experimental | Behavioral: Clinical Decision Support Tool (Moderate Risk), Behavioral: Clinical Decision Support Tool (High Risk)Pharmacies randomized to the experimental arm will be exposed to the intervention condition. Patients at the intervention pharmacy identified as at elevated risk will receive confirmatory screening for opioid risk. Those with confirmed moderate risk will receive a brief motivational intervention for medication misuse and an offer of naloxone dispensation. Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation. |
| Control Pharmacy Site | Other | Other: Standard of CareStandard of Care is the treatment as usual condition, which follows federal and Ohio state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Ohio State law requires pharmacist to not dispense an opioid supply >90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A large chain retail pharmacy chain in the Cincinnati or Columbus, Ohio area
Key exclusion criteria (2 listed)
- None
- This study does not involve individual patients as randomization will occur among pharmacies.
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 |
|---|---|---|
| Clinical Decision Support Tool (Moderate Risk)Moderate risk patients will get brief motivational intervention for medication misuse and an offer of naloxone dispensation. | Behavioural | Intervention Pharmacy Site |
| Clinical Decision Support Tool (High Risk)Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation. | Behavioural | Intervention Pharmacy Site |
| Standard of CareOhio State law requires pharmacist to not dispense an opioid supply >90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies. | Other | Control Pharmacy Site |
Primary outcome
Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool
Time frame: 24 months
This outcome will be assessed using the System Usability Scale (SUS).
Stage 2: Improvement in patient opioid-related risks
Time frame: 24 months
This outcome will be assessed using the Narcotic Score (NS).
Stage 3: ORRCDS sustainability within the system and pharmacy chain systems
Time frame: 24 months
Using the Consolidated Framework for Implementation Research the investigators will interview staff from the PDMP vendor and large chain retail pharmacy to assesses the barriers of tool sustainability.
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 17 Jul 2026.
- 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.
Jerry Cochran, PhD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool (Moderate Risk) and Clinical Decision Support Tool (High Risk) in people with Opioid Abuse and Prescription Opioid Abuse, 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. 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?
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?
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?
Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool (time frame: 24 months). The study lists 3 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 17 Jul 2026.