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Recruiting NCT07102446

Evaluation of an Opioid Stewardship Program in Non-Cancer Patients

No phase Interventional Pain Chronic Pain Opioid Analgesia Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opioid Stewardship Program.
Who it may be relevant to
Registry conditions: Pain, Chronic Pain, Opioid Analgesia, Opioid Use. Basic parameters: 19 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Other Opioid 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.

Primary outcome measures

  • Incidence of potentially high-risk opioid prescriptions [Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)]
Secondary outcome measures (3)
  • Average daily morphine milligram equivalent (MME) [Time frame: At each outpatient visit during the study evaluation period (up to 4 months per participant)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

South Korea · 1 center
  • Korea University Guro Hospital — Seoul

Identifiers

NCT: NCT07102446 · 2025GR0258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗