Evaluating a new packaging design for opioid medications
The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
This study is testing a new packaging design for oxycodone to see if it helps patients after orthopedic surgery use their pain medication more safely and effectively compared to regular bottles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UConn Health Academic / other |
| Locations | 1 site (Farmington, Connecticut) |
| Trial ID | NCT04598074 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of the Opioid Package Prototype (OPP) on the prescribing, dispensing, and patient use of oxycodone among patients undergoing orthopedic surgery. The study will compare the effectiveness of the OPP against standard amber vials in managing post-operative pain. It will also evaluate the feasibility of the new packaging for prescribers, pharmacists, and patients. Data collected will help optimize packaging and labeling to improve medication safety and usage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing orthopedic surgery and require oxycodone for post-operative pain management.
Not a fit: Patients not undergoing orthopedic surgery or those who do not require opioid medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective opioid prescribing practices, reducing the risk of misuse.
How similar studies have performed: While there have been studies on opioid packaging, this specific approach with the OPP is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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: -
Where this trial is running
Farmington, Connecticut
- UConn Health — Farmington, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA — University of Connecticut
- Study coordinator: Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
- Email: nathaniel.rickles@uconn.edu
- Phone: 860-486-6026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.