Opioid Package Prototype (OPP)

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
UConn Health
Study ID
NCT04598074
Status
Not Yet Recruiting

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Conditions

  • Opioid Prescribing, Dispensing, and Patient Use
  • Opioid Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opioid Package Prototype (OPP) — OTHER
    The Opioid Package Prototype (OPP) is a child-resistant/senior-friendly, calendar-blister packaging of limited pill counts with flat readable billboard space for medication labeling.
  • Usual Care (standard amber vial) — OTHER
    The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.

Study Details

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.

Key Dates

Start date
Sep 7, 2025
Status verified
Aug 2025
Primary completion
Jun 1, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Opioid Package Prototype (OPP)
    Oxycodone 5mg tablets dispensed in the Opioid Package Prototype (OPP) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient
  • Active Comparator: Usual Care (standard amber vial)
    Oxycodone 5mg tablets dispensed in the standard amber vial (usual care) with frequency and quantities varying, depending on the type of surgical procedure performed, surgeon, and individual patient

Primary Outcome Measure

Number of tablets of oxycodone prescribed [ Time Frame: 1 week after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06030
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
[email protected]
860-486-6026
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA (PRINCIPAL_INVESTIGATOR)
Katherine J Coyner, MD, FAOA (SUB_INVESTIGATOR)

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