New Opioid Packaging for Opioid Use Disorder
Recruiting in Palo Alto (17 mi)
Overseen ByNathaniel M Rickles, PharmD, PhD, BCPP, FAPhA
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: UConn Health
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The overall objective of this clinical trial is to identify the impact of selected package features, known as the Opioid Package Prototype (OPP), on the safe and effective use of opioids. Our specific aims are: (Aim 1) to evaluate the effectiveness of OPP on prescribing, dispensing, and patient use of oxycodone among orthopaedic surgery patients receiving post-operative outpatient oxycodone for post-surgical pain management, and (Aim 2) to determine the feasibility of OPP for orthopaedic surgery prescribers, pharmacists, and orthopaedic surgery patients. Such data can be used to further optimize packaging and labeling design, help patients and caregivers utilize their medication and packaging correctly, and improve prescribing and dispensing habits. The central hypothesis is that the OPP will be more effective than the amber vial in efforts to reduce oxycodone prescribing among patients over 18 receiving short-term management of post orthopedic surgery pain.
Is the new opioid packaging generally safe for humans?
The reformulated OxyContin, designed to deter tampering and abuse, has been studied for its potential to reduce misuse. While these studies focus on reducing abuse rather than direct safety, they suggest that the reformulated version is less likely to be tampered with, which could indirectly enhance safety by reducing misuse.
24568What data supports the effectiveness of the drug Opioid Package Prototype (OPP) for opioid use disorder?
Research shows that reformulated OxyContin, which is part of the OPP, is effective in reducing nonoral abuse, such as snorting and injecting, due to its abuse-deterrent properties. This suggests that the OPP may help reduce misuse and abuse of opioids.
12567How is the drug Opioid Package Prototype (OPP) different from other drugs for opioid use disorder?
The Opioid Package Prototype (OPP) is unique because it includes reformulated versions of oxycodone products like OxyContin, which are designed to deter tampering and abuse. These formulations make it harder to misuse the drug by crushing or dissolving it, reducing the risk of nonoral abuse such as snorting or injecting.
12356Do 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.
Eligibility Criteria
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
I am 18 years old or older.
I am having orthopedic surgery and will use opioids for pain after.
Participant Groups
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.
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
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UConn HealthFarmington, CT
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Who is running the clinical trial?
UConn HealthLead Sponsor
Food and Drug Administration (FDA)Collaborator
University of ConnecticutCollaborator
References
Assessing subjective and physiologic effects following intranasal administration of a new formulation of immediate release oxycodone HCl (Oxecta™) tablets in nondependent recreational opioid users. [2019]To evaluate the pharmacodynamic effects (subjective and physiologic) of a new formulation of immediate release oxycodone HCl (IRO-A; Oxecta™) tablets compared with immediate release oxycodone HCl (IRO; Roxicodone®) tablets when crushed and administered intranasally to nondependent recreational opioid users.
Attractiveness of reformulated OxyContin(R) tablets: assessing comparative preferences and tampering potential. [2013]Reformulated OxyContin® (oxycodone HCl controlled-release or ORF) was developed as a tamper and abuse-deterrent product, to reduce the risk of product abuse, misuse and their consequences. This noninterventional single-session study asked participants who were medically-healthy recreational opioid users, aged 18 years and older, to consider how they would use commonly available supplies to tamper with placebo ORF and placebo original OxyContin (OC) tablets, and how they would assess the attractiveness of tampering and abusing ORF tablets, as compared with other opioid formulations. Participants provided information on past opioid use, and they assessed the properties of five nonhypothetical oxycodone products and two hypothetical oxycodone products. Participants provided feedback on tampering preferences, preferred tamper methods for each product, overall tampering potential and product preferences. We had 30 participants (27 males and 3 females; mean age 35 years, range 18-51) complete both the interview and tampering sessions. Participants judged OC as the most attractive, valuable, desirable and most likely to be tampered with, from among all opioid products studied. By contrast, they rated ORF as the least attractive, least valuable, least desirable, and least likely to be tampered with among all the nonhypothetical opioid products studied. These results suggested that recreational drug abusers view ORF tablets as tamper-deterrent products.
The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers. [2014]Prescription opioid abuse is a significant public health concern that requires strategies to reduce its impact, including development of abuse deterrent formulations. OxyContin, an extended-release oxycodone (ERO) formulation, has been widely abused. This study assessed the effects of reformulated ERO, designed to be more difficult to manipulate for purposes of intranasal and intravenous abuse, on patterns of opioid abuse among a sample of individuals from rural Appalachia with a history of ERO abuse.
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. [2019]A new oxycodone formulation (Reformulated OxyContin® was released in Australia, early 2014. It was developed as a tamper-resistant ('abuse-deterrent') formulation of the drug. We summarize methods used in the National Opioid Medication Abuse Deterrence (NOMAD) study, which will examine: (i) whether there is a reduction in extra-medical use (including via tampering) of OxyContin® following the introduction of Reformulated OxyContin®; (ii) potential changes in extra-medical use of non-abuse-deterrent forms of oxycodone, other pharmaceutical opioids and illicit drugs; (iii) whether methods of tampering with Reformulated OxyContin® become widespread over time; (iv) Reformulated OxyContin®'s attractiveness on the illicit market; and (v) sales, prescriptions and harms related to OxyContin® and other drugs.
The introduction of a potentially abuse deterrent oxycodone formulation: Early findings from the Australian National Opioid Medications Abuse Deterrence (NOMAD) study. [2018]There is increasing concern about tampering of pharmaceutical opioids. We describe early findings from an Australian study examining the potential impact of the April 2014 introduction of an abuse-deterrent sustained-release oxycodone formulation (Reformulated OxyContin(®)).
A tale of 2 ADFs: differences in the effectiveness of abuse-deterrent formulations of oxymorphone and oxycodone extended-release drugs. [2021]The introduction of extended-release opioid analgesics helped initiate an epidemic of prescription opioid abuse in the United States. To make access to the drug by crushing or dissolution more difficult, abuse-deterrent formulations (ADFs) of OxyContin (Purdue Pharma, Stamford, CT) and Opana ER (Endo Pharmaceuticals Inc., Malvern, PA), which use the same foundation technology (Intac, Grunenthal, Aachen, Germany), were introduced in 2010 and 2012, respectively. To examine their relative effectiveness, we used a structured survey of 12,124 individuals entering treatment for opioid use disorder followed by a more focused online survey with a subset of these patients (N = 129) using both structured and open-ended questions. Data showed that the OxyContin ADF was highly effective in reducing nonoral abuse (91.4% before the ADF, 47.9% afterwards), particularly with insufflation (78%-28.8%) and intravenous injection of the active drug (42.7%-21.4%). However, although the Opana ER ADF was effective in reducing insufflation (80%-37.1%), injection (60.0%-51.4%), and overall nonoral abuse (94.3%-77.1%), it showed no significant decrease over time. Bearing in mind that the Opana ER sample was smaller in size than that for OxyContin, our results nonetheless suggest disparate outcomes resulting from the introduction of the ADFs, which could indicate that an ADF's effectiveness may be drug-specific. Given the public health impact of prescription opioids and the considerable effort being expended to develop ADFs as a partial solution to the problem, our preliminary studies suggest that each ADF must be evaluated on its own merits even if the same proprietary technology is used.
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. [2018]Oxycodone/naloxone (OXN PR) is a prolonged-release formulation containing oxycodone and naloxone in a 2:1 ratio. This study aimed to evaluate the tolerability and efficacy of doses up to OXN160/80 mg PR compared with oxycodone prolonged-release formulation (OxyPR) in a randomised controlled trial.
Reformulation of oxycodone 80 mg to prevent misuse: A cohort study assessing the impact of a supply-side intervention. [2021]In August 2010, extended-release OxyContin® products, including oxycodone 80 mg, were reformulated and released as abuse-deterrent medications. This paper describes changes in individual prescription filling patterns that followed the reformulation of oxycodone 80 mg.