Opioid Package Prototype (OPP)

The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.

NCT Number	NCT04598074
Lead Sponsor	UConn Health Collaborators: University of Connecticut, Food and Drug Administration (FDA)
Conditions	Opioid Use, Opioid Prescribing, Dispensing, and Patient Use
Enrollment	352 participants
Start Date	2025-09-07
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-05