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Opioid Package Prototype (OPP) for Opioid Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Opioid Use Disorder+1 MoreOpioid Package Prototype (OPP) - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Opioid Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Remifentanil
1
Sedatives
1
Opioid Agonist

Study Objectives

4 Primary · 16 Secondary · Reporting Duration: After dispensing all OPPs (approximately 2 years)

Month 1
Awareness of oxycodone medication information
Awareness of oxycodone tablets used
Consistency of access to oxycodone medication information
Month 3
Number of requests for additional oxycodone prescriptions
Peri-Operative Opioid-Related Symptom Distress Scale (OR-SDS)
3 months after surgery
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
Number of tablets of oxycodone prescribed
Year 2
Feasibility of OPP for pharmacists
Week 1
Change in knowledge of oxycodone from baseline to 1 week
Month 1
Patient Health Questionnaire-4 (PHQ-4)
Month 3
PEG (Pain, Enjoyment of Life and General Activity) score
Pain Catastrophizing Scale (PCS)
Pain Medication Attitudes Questionnaire (PMAQ-14) score
SANE (Single Assessment Numeric Evaluation) score
Month 3
Feasibility of OPP for orthopaedic surgery patients
Month 1
Amount of counseling time per oxycodone prescription for each study participant
Oxycodone
Month 1
Feasibility of OPP for orthopaedic surgery prescribers

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Remifentanil
1
Sedatives
1
Opioid Agonist

Trial Design

2 Treatment Groups

Usual Care (standard amber vial)
1 of 2
Opioid Package Prototype (OPP)
1 of 2

Active Control

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Opioid Package Prototype (OPP) · No Placebo Group · N/A

Opioid Package Prototype (OPP)
Other
Experimental Group · 1 Intervention: Opioid Package Prototype (OPP) · Intervention Types: Other
Usual Care (standard amber vial)
Other
ActiveComparator Group · 1 Intervention: Usual Care (standard amber vial) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after dispensing all opps (approximately 2 years)

Who is running the clinical trial?

University of ConnecticutOTHER
162 Previous Clinical Trials
156,246 Total Patients Enrolled
UConn HealthLead Sponsor
198 Previous Clinical Trials
57,888 Total Patients Enrolled
Food and Drug Administration (FDA)FED
152 Previous Clinical Trials
953,361 Total Patients Enrolled
Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhAPrincipal InvestigatorUniversity of Connecticut

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
the patient has a history of chronic opioid use The patient is receiving surgery that will involve the use of opioid medication for pain relief after the surgery is completed
the patient is able to travel to the pharmacy
however, the patient does not want to receive email notifications
the patient is less than 18 years old
the mother of the patient is the other
however, she is not willing to have surgery
The patient can read and understand the English language.
The patient understands what the study is and what they need to do.
References

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