PainNCT07102446
Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
A study testing Opioid Stewardship Program in people with Pain and Chronic Pain, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Pain, Chronic Pain, Opioid Analgesia
- What is being tested?
- Opioid Stewardship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2025to Jun 2026
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine \& Rehabilitation of the study site who received a prescription for opioid analgesics (oral, transdermal, sublingual, or buccal formulations containing oxycodone, fentanyl, tapentadol, hydrocodone, or morphine) due to chronic non-cancer pain during the study evaluation period (from IRB approval date to September 30, 2025)
- Adults aged ≥19 years and <80 years
- Patients who voluntarily signed a written informed consent form after receiving a full explanation of the study and understanding its purpose
Who cannot join
- Patients with active cancer
- Patients diagnosed with sickle cell disease
- Patients diagnosed with a life-limiting illness eligible for hospice or palliative care as defined in Article 2 of the 'ACT ON HOSPICE AND PALLIATIVE CARE AND DECISIONS ON LIFE-SUSTAINING TREATMENT FOR PATIENTS AT THE END OF LIFE'
- Pregnant patients
- Patients who were prescribed opioid analgesics within the past month for postoperative pain management
- Patients who were prescribed opioid analgesics within the past month for newly developed pain
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- Patients with communication difficulties
- Patients who were prescribed buprenorphine for the treatment of opioid use disorder
- Patients who are deemed inappropriate for study participation at the discretion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, Seoul, 08308
So Hyun Lee, MS, +82-2-2626-1611, pharm23@kumc.or.kr
So Hyun Lee, MS
About this study
The objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. This study compared OSP implementation with a historical control to determine whether it reduces the incidence of high-risk opioid prescribing and improves patients' awareness, knowledge, and attitudes about opioid use.
- Conditions
- Pain, Chronic Pain, Opioid Analgesia, Opioid Use
- Being tested
- Opioid Stewardship Program
- Keywords
- Pharmacist, Pain Management, Opioid Stewardship, Non-Cancer Pain
- Medical subject headings
- Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Stewardship ProgramOther
The Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Stewardship Program Intervention Group | Experimental | Participants in this arm are adult outpatients with chronic non-cancer pain who receive a pharmacist-led Opioid Stewardship Program (OSP) for their chronic opioid use. Receives: Other: Opioid Stewardship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of potentially high-risk opioid prescriptions
This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria:
- Prescription (Rx) of ER/SR opioids to patients with no prior opioid use
- Rx of certain ER/SR opioid dosages to patients who are not opioid-tolerant
- Rx of sublingual/buccal fentanyl
- Rx exceeding 50 MME/day
- Rx exceeding 10 MME/dose or 30 MME/day to patients with no prior opioid use
- Rx with no dose adjustments for the elderly or renally impaired with no prior opioid use
- ER/SR opioid conversions outside 50-75% of the prior MME/day
- Rx of oral ER/SR opioids more than twice daily
- Rx of transdermal fentanyl at intervals less than 72 hours
- Rx exceeding 30 days supply
- Rx without a pain assessment in the past 3 months in long-term opioid users
- No opioid dose adjustment in the last 3 Rx despite additional pain interventions and improved pain in long-term users
- No opioid dose adjustment in the last 3 Rx despite the lack of pain improvement in long-term users
Measured: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Secondary outcomes (3)
Average daily morphine milligram equivalent (MME)
This outcome assesses the clinical effect of the intervention by calculating the average daily MME for each opioid prescription during the study evaluation period.
Measured: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Change in opioid knowledge scores after education sessions compared to baseline
This outcome evaluates patient understanding of opioid use. Knowledge scores are measured at baseline (before the first education session) and after each of the education sessions using a validated questionnaire.
Measured: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Change in opioid attitude scores after education sessions compared to baseline
This outcome assesses patient attitudes toward opioid use, including concerns about addiction, side effects, and trust in physicians. Attitude scores are measured at baseline and after each of the education sessions using a modified K-PMAQ-14 (Korean version of pain medication attitude questionnaire-14) survey.
Measured: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start27 Jun 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Hospital Pharmaceutical Education & Research Center, Korea University
- Responsible party
- Principal investigator, Lee, So Hyun, Korea University Guro Hospital
- Investigators
- So Hyun Lee, MS, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102446
- Sponsor's protocol ID
- 2025GR0258
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision not to share individual participant data (IPD) is based on the possibility that the research data may contain personally identifiable information. Informed consent was not obtained from participants for the sharing of their individual data with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
- ClinicalTrials.gov ID
- NCT07102446
- Acronym / sponsor ID
- 2025GR0258
- Conditions
- Pain, Chronic Pain, Opioid Analgesia, Opioid Use
- Keywords
- Pharmacist, Pain Management, Opioid Stewardship, Non-Cancer Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Korea Hospital Pharmaceutical Education & Research Center, Korea University
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Aug 2025 (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 objective of this prospective, non-randomized clinical trial is to evaluate the effectiveness of a pharmacist-led Opioid Stewardship Program (OSP) in outpatient adults with chronic non-cancer pain. This study compared OSP implementation with a historical control to determine whether it reduces the incidence of high-risk opioid prescribing and improves patients' awareness, knowledge, and attitudes about opioid use.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid Stewardship Program Intervention Group | Experimental | Other: Opioid Stewardship ProgramParticipants in this arm are adult outpatients with chronic non-cancer pain who receive a pharmacist-led Opioid Stewardship Program (OSP) for their chronic opioid use. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine \& Rehabilitation of the study site who received a prescription for opioid analgesics (oral, transdermal, sublingual, or buccal formulations containing oxycodone, fentanyl, tapentadol, hydrocodone, or morphine) due to chronic non-cancer pain during the study evaluation period (from IRB approval date to September 30, 2025)
- Adults aged ≥19 years and <80 years
- Patients who voluntarily signed a written informed consent form after receiving a full explanation of the study and understanding its purpose
Key exclusion criteria (9 listed)
- Patients with active cancer
- Patients diagnosed with sickle cell disease
- Patients diagnosed with a life-limiting illness eligible for hospice or palliative care as defined in Article 2 of the 'ACT ON HOSPICE AND PALLIATIVE CARE AND DECISIONS ON LIFE-SUSTAINING TREATMENT FOR PATIENTS AT THE END OF LIFE'
- Pregnant patients
- Patients who were prescribed opioid analgesics within the past month for postoperative pain management
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 |
|---|---|---|
| Opioid Stewardship ProgramThe Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists. | Other | Opioid Stewardship Program Intervention Group |
Primary outcome
Incidence of potentially high-risk opioid prescriptions
Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)
This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria: * Prescription (Rx) of ER/SR opioids to patients with no prior opioid use * Rx of certain ER/SR opioid dosages to patients who are not opioid-tolerant * Rx of sublingual/buccal fentanyl * Rx exceeding 50 MME/day * Rx exceeding 10 MME/dose or 30 MME/day to patients with no prior opioid use * Rx with no dose adjustments for the elderly or renally impaired with no prior opioid use * ER/SR opioid conversions outside 50-75% of the prior MME/day * Rx of oral ER/SR opioids more than twice daily * Rx of transdermal fentanyl at intervals less than 72 hours * Rx exceeding 30 days supply * Rx without a pain assessment in the past 3 months in long-term opioid users * No opioid dose adjustment in the last 3 Rx despite additional pain interventions and improved pain in long-term users * No opioid dose adjustment in the last 3 Rx despite the lack of pain improvement in long-term users
3 secondary outcomes
Average daily morphine milligram equivalent (MME)
Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Change in opioid knowledge scores after education sessions compared to baseline
Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)
Change in opioid attitude scores after education sessions compared to baseline
Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)
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 3 Aug 2025.
- Individual participant dataSharing planned: No. The decision not to share individual participant data (IPD) is based on the possibility that the research data may contain personally identifiable information. Informed consent was not obtained from participants for the sharing of their individual data with third parties.
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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.
So Hyun Lee, MS principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Stewardship Program in people with Pain and Chronic Pain, run by Korea University Guro Hospital at 1 site in South Korea.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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 South Korea. 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?
Contact So Hyun Lee, MS (+82-2-2626-1611, pharm23@kumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of potentially high-risk opioid prescriptions (time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)). 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 3 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.