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Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

Recruiting
19-79 years
All
Phase N/A

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Overview

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

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

Study details
    Pain
    Chronic Pain
    Opioid Analgesia
    Opioid Use

NCT07102446

Korea University Guro Hospital

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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