Last reviewed · How we verify
NCT04598074
Opioid Package Prototype (OPP)
NA trial testing Opioid Package Prototype (OPP) in Opioid Use in 352 participants. Not yet recruiting.
1 June 2026
Quick facts
| Lead sponsor | UConn Health |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 352 |
| Start date | 7 September 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 30 September 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Opioid Package Prototype (OPP)
- Usual Care (standard amber vial)
Conditions studied
- Opioid Use — all drugs for Opioid Use →
- Opioid Prescribing, Dispensing, and Patient Use — all drugs for Opioid Prescribing, Dispensing, and Patient Use →
Sponsor
UConn Health — full company profile →
Who can join
18 and older, any sex, with Opioid Use or Opioid Prescribing, Dispensing, and Patient Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04598074
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04598074 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UConn Health
- Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04598074.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing