RecruitingNot ApplicableNCT07102446

Evaluation of an Opioid Stewardship Program in Non-Cancer Patients


Sponsor

Korea University Guro Hospital

Enrollment

70 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 79 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

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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.


Locations(1)

Korea University Guro Hospital

Seoul, Seoul, South Korea

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NCT07102446


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