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NCT Number: NCT07102446

Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

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.

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Key information

Conditions

Pain Agnosia Chronic Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Analgesia Opioid Use Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location status: Recruiting

Location contact

Boyoung Kim, MS

SUB_INVESTIGATOR

Chung-hun Lee, MD

SUB_INVESTIGATOR

Joon-shik Yoon, MD

SUB_INVESTIGATOR

Kyungim Kim, Ph.D.

SUB_INVESTIGATOR

Myounglae Kim, BS

SUB_INVESTIGATOR

Seolhee Jeon, BS

SUB_INVESTIGATOR

So Hyun Lee, MS

CONTACT

[email protected]

+82-2-2626-1611

So Hyun Lee, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Stewardship Program

Other

The Opioid Stewardship Program (OSP) includes pain and functional assessments, opioid prescription review and coordination, patient education, and counseling provided by trained pharmacists.

Primary outcomes

  1. Incidence of potentially high-risk opioid prescriptions

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

    This outcome measures the proportion of potentially high-risk opioid prescriptions based on predefined criteria:

    • Prescription (Rx) of ER/SR opioids to patients with no prior opioid use
    • Rx of certain ER/SR opioid dosages to patients who are not opioid-tolerant
    • Rx of sublingual/buccal fentanyl
    • Rx exceeding 50 MME/day
    • Rx exceeding 10 MME/dose or 30 MME/day to patients with no prior opioid use
    • Rx with no dose adjustments for the elderly or renally impaired with no prior opioid use
    • ER/SR opioid conversions outside 50-75% of the prior MME/day
    • Rx of oral ER/SR opioids more than twice daily
    • Rx of transdermal fentanyl at intervals less than 72 hours
    • Rx exceeding 30 days supply
    • Rx without a pain assessment in the past 3 months in long-term opioid users
    • No opioid dose adjustment in the last 3 Rx despite additional pain interventions and improved pain in long-term users
    • No opioid dose adjustment in the last 3 Rx despite the lack of pain improvement in long-term users

Secondary outcomes

  1. Average daily morphine milligram equivalent (MME)

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

    This outcome assesses the clinical effect of the intervention by calculating the average daily MME for each opioid prescription during the study evaluation period.

  2. Change in opioid knowledge scores after education sessions compared to baseline

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

    This outcome evaluates patient understanding of opioid use. Knowledge scores are measured at baseline (before the first education session) and after each of the education sessions using a validated questionnaire.

  3. Change in opioid attitude scores after education sessions compared to baseline

    Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)

    This outcome assesses patient attitudes toward opioid use, including concerns about addiction, side effects, and trust in physicians. Attitude scores are measured at baseline and after each of the education sessions using a modified K-PMAQ-14 (Korean version of pain medication attitude questionnaire-14) survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyungim Kim, Ph.D.

CONTACT

[email protected]

+82-44-860-1624

So Hyun Lee, MS

CONTACT

[email protected]

+82-2-2626-1611

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

  • Korea Hospital Pharmaceutical Education & Research Center
  • Korea University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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