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Opioid Package Prototype (OPP)

NCT04598074 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

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

Interventions

OTHER

Opioid Package Prototype (OPP)

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.

OTHER

Usual Care (standard amber vial)

The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER

  • Food and Drug Administration (FDA)

    collaborator FED

  • UConn Health

    lead OTHER

Principal Investigators

  • Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA · University of Connecticut

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-07
Primary Completion
2026-06-01
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04598074 on ClinicalTrials.gov