ClinicalTrials.gg
RecruitingNCT07102446Updated Aug 3, 2025

Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

An interventional study of Opioid Stewardship Program in Pain, Chronic Pain and Opioid Analgesia, sponsored by Korea University Guro Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-08-03.

Primary conditionChronic PainRegistry: PainReclassifiedWhy we changed it
Registry
Pain — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Pain
Why
  1. The study's listed conditions name Chronic Pain, a narrower term within Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
19 Years to 79 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Chronic Pain with a site in Korea, Republic of — 10 open to participants now, 11 under way, none of them phase 3. Chronic Pain · Korea, Republic of.

Planned enrollment
15th of 28
70 · median 76
Started
2025
with 2 others
No phase
22 of 36
8 open now
Primary completion
2025-12
later than 4 of 10 live
Registered
34th of 36
by date

Among the 36 studies in Chronic Pain with a site in Korea, Republic of, this one is the 15th largest by planned enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2025, is one of 22 with no phase, reaches primary completion later than 4 of the 10 other live ones, and was the 34th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

10 of the 36 studies in Chronic Pain with a site in Korea, Republic of are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 19 Years to 79 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Chronic Pain with a site in Korea, Republic of, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Pain
  • Chronic Pain
  • Opioid Analgesia
  • Opioid Use

Browse trials for

Keywords

  • Pharmacist
  • Pain Management
  • Opioid Stewardship
  • Non-Cancer Pain
04

In context

Chronic Pain Reclassified

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 2,387 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 89 studies on the registry; 17 are open to participants now.

Compared within Chronic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
19 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form after receiving a full explanation of the study and understanding its purpose

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Opioid Stewardship Program Intervention Group

    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.

    Other: Opioid Stewardship Program

Interventions

  • OtherOpioid Stewardship Program

    The Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists.

07

What researchers measure

Primary outcomes

  1. 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

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

Secondary outcomes

  1. 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.

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

  2. 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.

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

  3. 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.

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

08

Study locations

1 of 1 sites recruiting
  • Korea University Guro Hospital
    Seoul, Seoul 08308, South Korea
    Recruiting
    • So Hyun Lee, MS · Contactpharm23@kumc.or.kr · +82-2-2626-1611
    • So Hyun Lee, MS · Principal investigator
    • Boyoung Kim, MS · Sub investigator
    • Myounglae Kim, BS · Sub investigator
    • Seolhee Jeon, BS · Sub investigator
    • Chung-hun Lee, MD · Sub investigator
    • Joon-shik Yoon, MD · Sub investigator
    • Kyungim Kim, Ph.D. · Sub investigator
09

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Dec 2025, 6 months after the start.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 6 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2025
First posted
Aug 3, 2025
StartActual
Jun 27, 2025
Primary completionEst.
Dec 2025
CompletionEst.
Jun 2026
Last update
Aug 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07102446
Lead sponsor
Korea University Guro Hospital
Collaborators
Korea Hospital Pharmaceutical Education & Research Center, Korea University
Responsible party
Lee, So Hyun (Chief of Pharmacy Department, Korea University Guro Hospital) — Principal investigator
First posted
Aug 3, 2025
Start date
Jun 27, 2025
Primary completion
Dec 2025 (estimated)
Completion
Jun 2026 (estimated)
Last update
Aug 3, 2025

Study contacts

So Hyun Lee, MS
Contact
pharm23@kumc.or.kr
+82-2-2626-1611
Kyungim Kim, Ph.D.
Contact
kim_ki@korea.ac.kr
+82-44-860-1624
So Hyun Lee, MS
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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