Pharmacist-led opioid stewardship for adults with chronic non-cancer pain
Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
NA · Korea University Guro Hospital · NCT07102446
This program will test whether a pharmacist-led opioid stewardship program helps adults with chronic non-cancer pain reduce high-risk opioid prescriptions and improve their knowledge and attitudes about opioid use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Korea University Guro Hospital (other) |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT07102446 on ClinicalTrials.gov |
What this trial studies
This prospective, non-randomized interventional program introduces a pharmacist-led Opioid Stewardship Program (OSP) for outpatient adults with chronic non-cancer pain at Korea University Guro Hospital. The OSP includes pharmacist review of opioid prescriptions, patient education, and tailored recommendations communicated to prescribing clinicians. Outcomes from the implementation period will be compared with a historical control to measure changes in the incidence of high-risk opioid prescribing and in patients' awareness, knowledge, and attitudes about opioid use. Eligible participants are adults aged 19–79 who received specified opioid prescriptions in the designated departments during the study window.
Who should consider this trial
Good fit: Adults aged 19–79 with chronic non-cancer pain who received opioid prescriptions at the Department of Anesthesiology and Pain Medicine or the Department of Physical Medicine & Rehabilitation at Korea University Guro Hospital and who can give informed consent.
Not a fit: Patients with active cancer, sickle cell disease, those receiving hospice or palliative care, pregnant patients, or individuals not receiving outpatient opioid prescriptions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could lower high-risk opioid prescribing and improve patient safety and understanding about opioid use.
How similar studies have performed: Previous pharmacist-led opioid stewardship and multidisciplinary interventions have shown reductions in high-risk prescribing and improved patient education, so this approach has supportive precedent in the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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 informed consent form after receiving a full explanation of the study and understanding its purpose 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
Where this trial is running
Seoul, Seoul
- Korea University Guro Hospital — Seoul, Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: So Hyun Lee, MS — Korea University Guro Hospital
- Study coordinator: So Hyun Lee, MS
- Email: pharm23@kumc.or.kr
- Phone: +82-2-2626-1611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Chronic Pain, Opioid Analgesia, Opioid Use, Pharmacist, Pain Management, Opioid Stewardship, Non-Cancer Pain