Opioid Package Prototype (OPP)

Last updated: August 29, 2025
Sponsor: UConn Health
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pain

Drug Use

Treatment

Usual Care (standard amber vial)

Opioid Package Prototype (OPP)

Clinical Study ID

NCT04598074
20-210S-1
75F40119C10152
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient is 18 years and older;

  2. The patient is one of the participating surgeons;

  3. The patient is receiving orthopaedic surgery that involves the use of opioidmedication for post-operative pain;

  4. The patient is willing to receive oxycodone medication;

  5. The patient is willing and able to receive medication at the UConn Health SpecialtyPharmacy, located in the Exchange across the street from the main entrance of UConnHealth;

  6. The patient is willing and able to use a MyChart account;

  7. The patient is able to read and understand English; and

  8. The patient is able to understand the study procedures and their involvement in thestudy.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 352
Treatment Group(s): 2
Primary Treatment: Usual Care (standard amber vial)
Phase:
Study Start date:
September 07, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • UConn Health

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • UConn Health

    Farmington 4834272, Connecticut 4831725 06030
    United States

    Site Not Available

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