Not Yet RecruitingNot Applicable

Opioid Package Prototype (OPP)

United States352 participantsStarted 2025-09-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient is 18 years and older;
. The patient is one of the participating surgeons;
. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
. The patient is willing to receive oxycodone medication;
. 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;
. The patient is willing and able to use a MyChart account;
. The patient is able to read and understand English; and

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of tablets of oxycodone prescribed

Timeframe: 1 week after surgery

Number of tablets of oxycodone prescribed

Timeframe: 1 month after surgery

Number of tablets of oxycodone prescribed

Timeframe: 3 months after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 1 week after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 1 month after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 3 months after surgery

Number of oxycodone tablets used by study participants

Timeframe: 1 week after surgery

Trial details

NCT IDNCT04598074

SponsorUConn Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

860-486-6026 nathaniel.rickles@uconn.edu

View on ClinicalTrials.gov More Opioid Use trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The patient is 18 years and older;
. The patient is one of the participating surgeons;
. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
. The patient is willing to receive oxycodone medication;
. 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;
. The patient is willing and able to use a MyChart account;
. The patient is able to read and understand English; and

What they're measuring

Number of tablets of oxycodone prescribed

Timeframe: 1 week after surgery

Number of tablets of oxycodone prescribed

Timeframe: 1 month after surgery

Number of tablets of oxycodone prescribed

Timeframe: 3 months after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 1 week after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 1 month after surgery

Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant

Timeframe: 3 months after surgery

Number of oxycodone tablets used by study participants

Timeframe: 1 week after surgery