Trial reportPain medicine (Malden, Mass.)2015
Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties.
Trial report in Pain medicine (Malden, Mass.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 44 citations in OpenAlex.
- Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain.Clinical drug investigation · 2020Trial
- Oral Human Abuse Potential of Oxycodone DETERxJournal of clinical pharmacology · 2017Trial
- The Practices of Public Hospital Registered Nurses Regarding Post-Stroke Dysphagia, in China.Journal of multidisciplinary healthcare · 2025Article
- Postmarketing Research for Opioid Abuse-Deterrent Formulations: A Narrative Review.Journal of pain research · 2025Review
- Review of Opioid Abuse-Deterrent Formulations: Impact and Barriers to Access.Journal of pain research · 2024Review
- A Chewing Study of Abuse-Deterrent Tablets Containing Polyethylene Oxide Using a Robotic Simulator.AAPS PharmSciTech · 2023Article
- Crushed Tablet Administration for Patients with Dysphagia and Enteral Feeding: Challenges and Considerations.Drugs & aging · 2023Review
- Nonmedical Use of XtampzaJournal of pain research · 2021Article
- Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone.Clinical pharmacokinetics · 2019Review
- Relative Abuse of Crush-Resistant Prescription Opioid Tablets via Alternative Oral Modes of Administration.Pain medicine (Malden, Mass.) · 2018Article
- A Brief History of the Opioid Epidemic and Strategies for Pain Medicine.Pain and therapy · 2018Review
- America's Opioid Epidemic: a Comprehensive Review and Look into the Rising Crisis.Current pain and headache reports · 2018Review
- In Vitro Drug Release After Crushing: Evaluation of XtampzaClinical drug investigation · 2017Article
- Response to Crudele et al. Commentary on Gudin et al. "Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties".Pain medicine (Malden, Mass.) · 2017Article
- In response to Gudin et al. - Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties.Pain medicine (Malden, Mass.) · 2017Article
- Review
- Oral drug therapy in elderly with dysphagia: between a rock and a hard place!Clinical interventions in aging · 2017Review
- Oxycodone DETERxDrugs · 2016Review
- Oxycodone DETERxPain and therapy · 2016Review
- Drug Formulation Advances in Extended-Release Medications for Pain Control.Current pain and headache reports · 2016Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveOxycodone DETERx® is an extended-release (ER), microsphere-in-capsule abuse-deterrent-formulation designed to retain its extended-release properties following tampering or misuse (e.g., chewing, crushing). This study assessed the safety and pharmacokinetics of orally administered intact and crushed Oxycodone DETERx® capsules compared with intact and crushed reformulated OxyContin® tablets and crushed immediate-release oxycodone tablets (IR oxycodone).
methodsThis was a randomized, open-label, active-controlled, cross-over study. Healthy subjects received five oxycodone treatments (40 mg) with a standardized high-fat, high-calorie meal: Oxycodone DETERx® (intact or crushed), OxyContin® (intact or crushed), and IR oxycodone (crushed). Blood samples were collected for assessment of oxycodone plasma concentrations.
resultsThirty-eight subjects completed the study. Both crushed and intact Oxycodone DETERx® resulted in lower peak plasma concentrations when compared with IR oxycodone. Crushed Oxycodone DETERx® was bioequivalent to intact Oxycodone DETERx® and exhibited a numerically lower Cmax . Also, median Tmax was unchanged by crushing. In contrast, mean peak plasma oxycodone concentrations for crushed OxyContin® were significantly higher compared with intact OxyContin® and were bioequivalent to IR oxycodone. Median Tmax for crushed OxyContin® was the same as IR oxycodone and 3.25 hours shorter than intact OxyContin®.
conclusionsThese data demonstrate that when crushed and taken orally, Oxycodone DETERx® maintains its EXTENDED-release profile, while crushed OxyContin® shows a pharmacokinetic profile similar to an immediate-release product. These results suggest that Oxycodone DETERx® may be less attractive to illicit drug users compared with existing abuse-deterrent-formulations, while providing a safer option for patients who may unknowingly crush their medication such as those who have difficulty swallowing.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.