Your session is about to expire
← Back to Search
New Opioid Packaging for Opioid Use Disorder
N/A
Recruiting
Led By Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
Research Sponsored by UConn Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient is 18 years and older
The patient is receiving orthopaedic surgery that involves the use of opioid medication for post-operative pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after dispensing all opps (approximately 2 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new type of packaging for opioids is more effective in reducing prescribing than the current type of packaging.
Who is the study for?
This trial is for adults over 18 who are undergoing outpatient orthopaedic surgery and need opioids like oxycodone for post-surgery pain. Participants must be able to use a MyChart account, understand English, and agree to get their medication from UConn Health Specialty Pharmacy.
What is being tested?
The study is testing the Opioid Package Prototype (OPP), which aims to improve how patients receive and manage their opioid medications after surgery. It will compare OPP's effectiveness with usual care using standard amber vials in prescribing, dispensing, and patient usage.
What are the potential side effects?
While this trial focuses on packaging rather than medication effects directly, typical opioid side effects can include drowsiness, constipation, nausea, addiction risk, and respiratory depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am having orthopedic surgery and will use opioids for pain after.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after dispensing all opps (approximately 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after dispensing all opps (approximately 2 years)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average morphine milligram equivalent (MME) of oxycodone tablets prescribed/per participant
Average morphine milligram equivalent (MME) of oxycodone tablets used/per participant
Number of oxycodone tablets used by study participants
+1 moreSecondary study objectives
Amount of counseling time per oxycodone prescription for each study participant
Oxycodone
Awareness of oxycodone medication information
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Opioid Package Prototype (OPP)Experimental Treatment1 Intervention
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
Group II: Usual Care (standard amber vial)Active Control1 Intervention
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
Find a Location
Who is running the clinical trial?
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,297 Total Patients Enrolled
University of ConnecticutOTHER
191 Previous Clinical Trials
160,480 Total Patients Enrolled
UConn HealthLead Sponsor
215 Previous Clinical Trials
60,369 Total Patients Enrolled
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhAPrincipal InvestigatorUniversity of Connecticut