Opioid UseNCT04598074
Opioid Package Prototype (OPP)
A study testing Opioid Package Prototype (OPP) in people with Opioid Use and Opioid Prescribing, Dispensing, and Patient Use, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Prescribing, Dispensing, and Patient Use
- What is being tested?
- Opioid Package Prototype (OPP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- The patient is able to understand the study procedures and their involvement in the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UConn Health
Farmington, Connecticut, 06030
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA, 860-486-6026, nathaniel.rickles@uconn.edu
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
About this study
Official title: The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
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.
- Being tested
- Opioid Package Prototype (OPP), Usual Care (standard amber vial)
- Keywords
- oxycodone, opioid, opioids, package, packaging, post-surgical pain, post-operative pain, orthopedic, orthopaedic, surgery, dispensing, prescribing, blister, tablets, pain, opioid package prototype, OPP
- Medical subject headings
- Pain, Postoperative, Blister, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Package Prototype (OPP)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)Other
The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Package Prototype (OPP) | Experimental | 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 Receives: Other: Opioid Package Prototype (OPP) |
| Usual Care (standard amber vial) | Active comparator | 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 Receives: Other: Usual Care (standard amber vial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Measured: 1 week after surgery
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Measured: 1 month after surgery
Number of tablets of oxycodone prescribed
Count via medical/pharmacy records
Measured: 3 months after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Measured: 1 week after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Measured: 1 month after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Mean
Measured: 3 months after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Measured: 1 week after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Measured: 1 month after surgery
Number of oxycodone tablets used by study participants
Count via survey/interview/visual inspection/photograph
Measured: 3 months after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Measured: 1 week after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Measured: 1 month after surgery
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Mean
Measured: 3 months after surgery
Secondary outcomes (16)
Number of requests for additional oxycodone prescriptions
Count per patient survey/interview
Measured: 1 week, 1 month and 3 months after surgery
Amount of dispensing time per oxycodone prescription for each study participant
Log of dispensing start time (received prescription) and dispensing stop time (prescription ready for pick up)
Measured: Time of surgery and any refills up to 1 month after surgery
Amount of counseling time per oxycodone prescription for each study participant
Log of counseling start time (start to discuss medication information) and counseling stop time (complete discussion of medication information)
Measured: Time of surgery and any refills up to 1 month after surgery
Awareness of oxycodone tablets used
Amount of time to report number of tablets used via brief inspection of container (not manual count) during interview and various survey questions
Measured: 1 week and 1 month after surgery
Change in knowledge of oxycodone from baseline to 1 week
Number of correct answers out of 4 knowledge questions
Measured: Baseline (before surgery) and 1 week after surgery
Awareness of oxycodone medication information
Various survey/interview questions
Measured: 1 week and 1 month after surgery
Consistency of access to oxycodone medication information
Various survey/interview questions
Measured: 1 week and 1 month after surgery
SANE (Single Assessment Numeric Evaluation) score
"How would you rate your affected joint/region of interest today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Measured: Baseline, 1 week, 1 month and 3 months after surgery
PEG (Pain, Enjoyment of Life and General Activity) score
A three-item scale assessing pain intensity and interference from 0-10. The three item scores are averaged for a final score and a higher number indicates greater pain and interference.
Measured: Baseline, 1 week, 1 month and 3 months after surgery
Pain Medication Attitudes Questionnaire (PMAQ-14) score
Participants indicate the degree to which they agree with 14 statements regarding pain medication from 0 (never true) to 5 (always true). The 14 scores are averaged for a final score and a higher number indicates a more negative attitude toward pain medications,
Measured: Baseline, 1 week, 1 month and 3 months after surgery
Pain Catastrophizing Scale (PCS)
A 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Measured: Baseline, 1 week, 1 month and 3 months after surgery
Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)
A 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.
Measured: 1 week, 1 month and 3 months after surgery
Patient Health Questionnaire-4 (PHQ-4)
A 4-item inventory rated on a 4-point Likert-type scale to assess for anxiety and depression. The minimum score (0) indicates no psychological distress and the maximum score (12) indicates severe psychological distress.
Measured: Baseline, 1 week and 1 month after surgery
Feasibility of OPP for orthopaedic surgery prescribers
Interview regarding benefits and weaknesses of the OPP design, interest in prescribing OPP in the future, and how OPP design can be improved for the future
Measured: Within 1 month after prescribing the OPP to 30 participants
Feasibility of OPP for pharmacists
Interview questions regarding benefits and weaknesses of the OPP design, interest in dispensing OPP in the future, and how OPP design can be improved for the future
Measured: After dispensing all OPPs (approximately 2 years)
Feasibility of OPP for orthopaedic surgery patients
Interview questions regarding benefits and weaknesses of the OPP design, interest in using OPP in the future, and how OPP design can be improved for the future
Measured: Between 1 and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start7 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Nathaniel Rickles, UConn Health
- Investigators
- Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598074
- Sponsor's protocol ID
- 20-210S-1
- Other IDs
- 75F40119C10152
- Status last verified
- Aug 2025
- First submitted
- 7 Oct 2020
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
- ClinicalTrials.gov ID
- NCT04598074
- Acronym / sponsor ID
- 20-210S-1
- Keywords
- oxycodone, opioid, opioids, package, packaging, post-surgical pain, post-operative pain, orthopedic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Connecticut, Food and Drug Administration (FDA)
- Study start
- 7 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Package Prototype (OPP) | Experimental | Other: 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 |
| Usual Care (standard amber vial) | Active comparator | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Opioid Package Prototype (OPP) |
| Usual Care (standard amber vial)The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study. | Other | Usual Care (standard amber vial) |
Primary outcome
Number of tablets of oxycodone prescribed
Time frame: 1 week after surgery
Count via medical/pharmacy records
Number of tablets of oxycodone prescribed
Time frame: 1 month after surgery
Count via medical/pharmacy records
Number of tablets of oxycodone prescribed
Time frame: 3 months after surgery
Count via medical/pharmacy records
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Time frame: 1 week after surgery
Mean
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Time frame: 1 month after surgery
Mean
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Time frame: 3 months after surgery
Mean
Number of oxycodone tablets used by study participants
Time frame: 1 week after surgery
Count via survey/interview/visual inspection/photograph
Number of oxycodone tablets used by study participants
Time frame: 1 month after surgery
Count via survey/interview/visual inspection/photograph
Number of oxycodone tablets used by study participants
Time frame: 3 months after surgery
Count via survey/interview/visual inspection/photograph
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Time frame: 1 week after surgery
Mean
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Time frame: 1 month after surgery
Mean
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Time frame: 3 months after surgery
Mean
16 secondary outcomes
Number of requests for additional oxycodone prescriptions
Time frame: 1 week, 1 month and 3 months after surgery
Amount of dispensing time per oxycodone prescription for each study participant
Time frame: Time of surgery and any refills up to 1 month after surgery
Amount of counseling time per oxycodone prescription for each study participant
Time frame: Time of surgery and any refills up to 1 month after surgery
Awareness of oxycodone tablets used
Time frame: 1 week and 1 month after surgery
Change in knowledge of oxycodone from baseline to 1 week
Time frame: Baseline (before surgery) and 1 week after surgery
Awareness of oxycodone medication information
Time frame: 1 week and 1 month after surgery
Consistency of access to oxycodone medication information
Time frame: 1 week and 1 month after surgery
SANE (Single Assessment Numeric Evaluation) score
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
PEG (Pain, Enjoyment of Life and General Activity) score
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Pain Medication Attitudes Questionnaire (PMAQ-14) score
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Pain Catastrophizing Scale (PCS)
Time frame: Baseline, 1 week, 1 month and 3 months after surgery
Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)
Time frame: 1 week, 1 month and 3 months after surgery
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline, 1 week and 1 month after surgery
Feasibility of OPP for orthopaedic surgery prescribers
Time frame: Within 1 month after prescribing the OPP to 30 participants
Feasibility of OPP for pharmacists
Time frame: After dispensing all OPPs (approximately 2 years)
Feasibility of OPP for orthopaedic surgery patients
Time frame: Between 1 and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Package Prototype (OPP) in people with Opioid Use and Opioid Prescribing, Dispensing, and Patient Use, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA (860-486-6026, nathaniel.rickles@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tablets of oxycodone prescribed (time frame: 1 week after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.