Evaluation of an Opioid Stewardship Program in Non-Cancer Patients (NCT07102446) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
South Korea70 participantsStarted 2025-06-27
Plain-language 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.
Who can participate
Age range19 Years – 79 Years
SexALL
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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
What they're measuring
1
Incidence of potentially high-risk opioid prescriptions
Timeframe: At each outpatient visit during the study evaluation period (up to 4 months per participant)