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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 below

Select...

I am 18 years old or older.

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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)

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

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 more

Secondary study objectives

Amount of counseling time per oxycodone prescription for each study participant

Oxycodone

Awareness of oxycodone medication information

+13 more

Awards & 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

0 / 2Eligibility criteria met