Clinical trial · Interventional
Evaluation of an Opioid Stewardship Program in Non-Cancer Patients
NCT07102446CI-TRIAL-00093012recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Opioid Analgesia | — | UNRESOLVED | — |
| Opioid Use | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opioid Stewardship Program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Opioid Stewardship Program Intervention 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.
- interventionNames
- Other: Opioid Stewardship Program
Primary outcomes (1)
- measure
- Incidence of potentially high-risk opioid prescriptions
- timeFrame
- At each outpatient visit during the study evaluation period (up to 4 months per participant)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.