← 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

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am 18 years old or older.
Select...
I am having orthopedic surgery and will use opioids for pain after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after dispensing all opps (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after dispensing all opps (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
Amount of counseling time per oxycodone prescription for each study participant
Oxycodone
Awareness of oxycodone medication information
+13 more

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?

UConn HealthLead Sponsor
211 Previous Clinical Trials
60,269 Total Patients Enrolled
University of ConnecticutOTHER
181 Previous Clinical Trials
157,844 Total Patients Enrolled
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,254 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are further participants being taken into this research endeavor?

"Yes, as per the information on clinicaltrials.gov this investigation is actively recruiting participants. It was originally posted on September 7th 2021 and most recently revised on April 30th 2022."

Answered by AI

How many participants have been recruited to the trial thus far?

"Indeed, the clinical study is currently recruiting participants. This trial was posted to the site on September 7th 2021 and it's most recent update occured April 30th 2022. 450 patients are sought at one location for this medical inquiry."

Answered by AI

What therapeutic benefits are anticipated from this research endeavor?

"The primary aim of this clinical experiment is to evaluate the quantity of Oxycodone tablets prescribed over a three-month period after surgery. Secondary metrics include the number of requests for additional medication per patient, Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS) which assesses 3 dimensions related to frequency and severity, as well as Patient Health Questionnaire 4 (PHQ4), a 4 item inventory rated on a Likert scale used to gauge anxiety and depression levels."

Answered by AI
~106 spots leftby May 2025