Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

Korea University

Status: Enrolling

Conditions: Chronic Pain; Opioid Use; Opioid Analgesia; Pain

Treatments: Other: Opioid Stewardship Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07102446

2025GR0258

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Opioid Stewardship Program Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Opioid Stewardship Program