New Opioid Packaging for Opioid Use Disorder

Overseen By Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Must be taking: Opioids

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new packaging for oxycodone, a painkiller often prescribed after orthopedic surgery, to determine if it helps patients use the medication more safely and effectively. Researchers aim to assess whether the new packaging, called the Opioid Package Prototype (OPP), can improve how doctors prescribe it, how pharmacists dispense it, and how patients take it compared to the usual amber vial. The trial may suit patients undergoing orthopedic surgery who will need oxycodone for pain relief afterward and are willing to pick up their medication from a specific pharmacy. As an unphased trial, this study allows patients to contribute to research that could enhance medication safety and effectiveness.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the use of oxycodone for post-surgical pain management.

What prior data suggests that the Opioid Package Prototype (OPP) is safe for use in opioid prescribing and dispensing?

Research shows that the Opioid Package Prototype (OPP) is being tested to determine if it can help people use opioids, like oxycodone, more safely after surgery. Although specific safety data for the OPP itself is not available, the study examines how packaging can enhance medication safety.

The trial involves standard oxycodone, a common painkiller with well-documented effects and risks. Safety concerns, such as addiction and overdose, are addressed by improving the drug's packaging and usage.

This trial does not test a new drug but explores a new packaging method for an existing one. The safety profile of oxycodone is already well-known. The OPP aims to reduce misuse and improve patient adherence to medication instructions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Opioid Package Prototype (OPP) because it offers a new way to manage opioid use disorder through innovative packaging rather than changing the medication itself. Unlike the standard amber vial packaging, the OPP aims to adjust the dispensing method, potentially improving how opioids are managed after surgeries. This approach could help tailor opioid distribution to each patient's specific needs, possibly reducing the risk of misuse or overuse.

What evidence suggests that the Opioid Package Prototype (OPP) is effective for opioid use disorder?

This trial will compare the Opioid Package Prototype (OPP) with the usual care packaging for oxycodone. Research shows that the OPP is designed to enhance the safety of opioids, like oxycodone, by altering their packaging. Although specific results on the OPP's effectiveness are not yet available, the concept is that improved packaging might help regulate opioid administration and usage. Studies have found that changing packaging can affect medication use and safety. While the OPP remains under investigation in this trial, the goal is to determine if it can reduce opioid misuse after surgery, thereby making their use safer for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Nathaniel M Rickles, PharmD, PhD, BCPP, FAPhA

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The patient is able to read and understand English

The patient is willing and able to use a MyChart account

I am willing to take oxycodone for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxycodone 5mg tablets dispensed in the Opioid Package Prototype (OPP) or standard amber vial for post-operative pain management

3 months

Baseline, 1 week, 1 month, and 3 months after surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of anxiety, depression, pain, and medication use

3 months

1 week, 1 month, and 3 months after surgery

Feasibility Assessment

Interviews conducted to assess the feasibility of the Opioid Package Prototype (OPP) for prescribers, pharmacists, and patients

1-3 months after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Opioid Package Prototype (OPP)
• Usual Care (standard amber vial)

Trial Overview

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.

How Is the Trial Designed?

Group I: Opioid Package Prototype (OPP) Experimental Treatment 1 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 Control 1 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

Opioid Package Prototype (OPP) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as OxyContin for:

• Moderate to severe pain
• Chronic pain

Approved in European Union as OxyNorm for:

• Moderate to severe pain
• Chronic pain

Approved in Canada as OxyContin for:

• Moderate to severe pain
• Chronic pain

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Published Research Related to This Trial

The introduction of the abuse-deterrent formulation of OxyContin(®) in April 2014 led to an 80% decline in pharmacy sales of the 80mg version, which was commonly misused by people who inject drugs (PWID).

Post-introduction, there was a significant drop in the use of OxyContin(®) among PWID, with visits to the Sydney Medically Supervised Injecting Centre for OxyContin(®) injection decreasing from 62% to just 5%, indicating that the reformulated product was less attractive for tampering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The introduction of a potentially abuse deterrent oxycodone formulation: Early findings from the Australian National Opioid Medications Abuse Deterrence (NOMAD) study. Degenhardt, L., Bruno, R., Ali, R., et al.[2018]

After the reformulation of OxyContin® in 2010, over half of the 4,098 New York City residents studied changed their prescription filling patterns, with 14% discontinuing opioid prescriptions, 46% continuing with oxycodone 80 mg, and 40% switching to lower doses like oxycodone 30 mg.

The median morphine milligram equivalents (MME) significantly decreased across all groups post-reformulation, suggesting that the reformulation may have led some individuals to seek alternative sources, such as heroin, to manage withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reformulation of oxycodone 80 mg to prevent misuse: A cohort study assessing the impact of a supply-side intervention. Nolan, ML., Harocopos, A., Allen, B., et al.[2021]

In a study involving 40 nondependent recreational opioid users, the new formulation of immediate release oxycodone (IRO-A) resulted in significantly lower subjective ratings of 'drug liking' and 'overall drug liking' compared to the standard immediate release oxycodone (IRO) when both were crushed and administered intranasally.

While both formulations caused common opioid-related side effects, IRO-A was associated with more nasal-related symptoms, suggesting that although it may be less appealing for recreational use, it still carries risks of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing subjective and physiologic effects following intranasal administration of a new formulation of immediate release oxycodone HCl (Oxecta™) tablets in nondependent recreational opioid users. Schoedel, KA., Rolleri, RL., Faulknor, JY., et al.[2019]

The abuse-deterrent formulation (ADF) of OxyContin significantly reduced nonoral abuse rates from 91.4% to 47.9%, particularly for methods like insufflation and intravenous injection, indicating its effectiveness in curbing misuse.

In contrast, while the Opana ER ADF also reduced nonoral abuse rates, it did not show a significant decrease over time, suggesting that the effectiveness of ADFs may vary by drug, even when using the same technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tale of 2 ADFs: differences in the effectiveness of abuse-deterrent formulations of oxymorphone and oxycodone extended-release drugs. Cicero, TJ., Ellis, MS., Kasper, ZA.[2021]

In a study of 243 patients over 5 weeks, oxycodone/naloxone prolonged-release (OXN PR) significantly improved bowel function compared to oxycodone prolonged-release (OxyPR), with greater reductions in opioid-induced constipation as measured by the bowel function index.

Both treatments provided similar levels of pain relief, but patients on OXN PR required less laxative rescue medication and experienced a doubling in complete spontaneous bowel movements, indicating that OXN PR can effectively manage pain without compromising bowel health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase III randomized controlled study on the efficacy and improved bowel function of prolonged-release (PR) oxycodone-naloxone (up to 160/80 mg daily) vs oxycodone PR. Dupoiron, D., Stachowiak, A., Loewenstein, O., et al.[2018]

In a study with 30 recreational opioid users, participants found the reformulated OxyContin® (ORF) to be significantly less attractive and less likely to be tampered with compared to the original OxyContin (OC), indicating its effectiveness as a tamper-deterrent product.

Participants rated the original OxyContin as the most desirable and valuable opioid product, suggesting that the reformulated ORF successfully reduces the appeal for misuse among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attractiveness of reformulated OxyContin(R) tablets: assessing comparative preferences and tampering potential. Sellers, EM., Perrino, PJ., Colucci, SV., et al.[2013]

The reformulated extended-release oxycodone (ERO) showed significantly lower rates of abuse (33% prevalence) compared to the original ERO and immediate-release oxycodone (IR oxycodone), indicating its effectiveness in reducing misuse among individuals with a history of opioid abuse.

After the reformulation, the prevalence of original ERO abuse declined significantly, and there was no evidence that the reformulated ERO became a substitute for the original, suggesting that the new formulation successfully deterred abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. Havens, JR., Leukefeld, CG., DeVeaugh-Geiss, AM., et al.[2014]

The NOMAD study aims to evaluate the effectiveness of the new tamper-resistant formulation of OxyContin® in reducing extra-medical use and tampering, using a comprehensive approach that includes routine data analysis and a cohort of 606 individuals who misuse opioids.

This study is significant as it is one of the most thorough investigations into the impact of an opioid medication on misuse and diversion, which could provide valuable insights for policymakers and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the potential impact of a reformulated version of oxycodone upon tampering, non-adherence and diversion of opioids: the National Opioid Medications Abuse Deterrence (NOMAD) study protocol. Degenhardt, L., Larance, B., Bruno, R., et al.[2019]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK553166/

Opioid Use Disorder: Evaluation and Management - NCBI - NIH

Concerningly, OUD results in over 120,000 and 47,000 deaths per year ... Continued opioid use despite social and interpersonal consequences.

2.

fda.gov

fda.gov/media/114948/download

Opioid Use Disorder: Endpoints for Demonstrating ...

In general, clinical trials evaluating effectiveness of drugs for treating OUD have used reduction in drug-taking behavior (drug use patterns) as an endpoint.

3.

cdc.gov

cdc.gov/overdose-prevention/data-research/facts-stats/moud-study.html

Medications for Opioid Use Disorder (MOUD) Study

The MOUD study examined patient outcomes from several opioid use disorder (OUD) treatments.

4.

federalregister.gov

federalregister.gov/documents/2024/02/02/2024-01693/medications-for-the-treatment-of-opioid-use-disorder

Medications for the Treatment of Opioid Use Disorder

This final rule modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7861202/

Outcomes for patients receiving telemedicine-delivered ...

Effective evidence-based treatments for Opioid Use Disorder (OUD) exist. ... Treatment outcome data (retention and opioid toxicology screens) are reported ...

6.

fda.gov

fda.gov/media/126835/download

Timeline of Selected FDA Activities and Significant Events ...

December: On December 16, the FDA approved several safety labeling changes (SLCs) about the serious risks of prescription opioid analgesics and opioids approved ...

7.

medinform.jmir.org

medinform.jmir.org/2024/1/e53625

A Machine Learning Application to Classify Patients at ...

This study aimed to assess the clinical validity of an ML application designed to identify and alert clinicians of different levels of OUD risk.