Opioid Package Prototype (OPP)

NCT ID: NCT04598074

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Opioid Package Prototype (OPP)

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Usual Care (standard amber vial)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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 opioid medication 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 Specialty Pharmacy, located in the Exchange across the street from the main entrance of UConn Health;

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 the study.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Connecticut

OTHER

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Rickles

Professor of Pharmacy Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

UConn Health

Farmington, Connecticut, United States

Countries

United States

Central Contacts

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

Role: CONTACT

nathaniel.rickles@uconn.edu

860-486-6026

Facility Contacts

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

Role: primary

nathaniel.rickles@uconn.edu

860-486-6026

Other Identifiers

75F40119C10152

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-210S-1

Identifier Type: -

Identifier Source: org_study_id