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Opioid Package Prototype (OPP)

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 5, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: May 2025 to Jun 1, 2026v8 Show 4 more changesShow less
    • Start date: Sep 7, 2021 to Sep 7, 2025
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: May 2025 to Sep 30, 2026
    • Site details revised
  2. Primary and study completion dates: Sep 2023 to May 2025v7
  3. Enrollment target: 450 to 352
    • Eligibility criteria shortened, about 1 word
    v6
  4. Primary and study completion dates: Jun 2022 to Sep 2023
    • Enrollment target: 420 to 450
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2021 to Sep 7, 2021
    • Eligibility criteria expanded, about 32 words
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Apr 2021 to Jul 2021v3
  2. Start date: Oct 2020 to Apr 2021
    • Primary and study completion dates: Feb 2022 to Jun 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UConn Health
38 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT04598074
Lead Sponsor UConn Health
Collaborators: University of Connecticut, Food and Drug Administration (FDA)
Conditions
(from sponsor)		 Opioid Use, Opioid Prescribing, Dispensing, and Patient Use
Related terms Blister, Pain, Postoperative Pain
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov