NOT_YET_RECRUITING

Opioid Package Prototype (OPP)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes

Quick Facts

Study Start:2025-09-07
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:NOT_YET_RECRUITING

Study ID

NCT04598074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The patient is 18 years and older;
  2. 2. The patient is one of the participating surgeons;
  3. 3. The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain;
  4. 4. The patient is willing to receive oxycodone medication;
  5. 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. 6. The patient is willing and able to use a MyChart account;
  7. 7. The patient is able to read and understand English; and
  8. 8. The patient is able to understand the study procedures and their involvement in the study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
CONTACT
860-486-6026
nathaniel.rickles@uconn.edu

Principal Investigator

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
PRINCIPAL_INVESTIGATOR
University of Connecticut

Study Locations (Sites)

UConn Health
Farmington, Connecticut, 06030
United States

Collaborators and Investigators

Sponsor: UConn Health

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-07
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-09-07
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • oxycodone
  • opioid
  • opioids
  • package
  • packaging
  • post-surgical pain
  • post-operative pain
  • orthopedic
  • orthopaedic
  • surgery
  • dispensing
  • prescribing
  • blister
  • tablets
  • pain
  • opioid package prototype
  • OPP

Additional Relevant MeSH Terms

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