title: Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients.
abstract: OBJECTIVE
  Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT).
  
  
  METHODS
  The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use.
  
  
  METHODS
  The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada.
  
  
  METHODS
  Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period.
  
  
  METHODS
  This was a noninterventional study.
  
  
  METHODS
  The main outcome was the number of oxycodonepositive UDSs.
  
  
  RESULTS
  The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted.
  
  
  CONCLUSIONS
  The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.
authors.affiliation: Physician, Satellite Comprehensive Care Addictions Clinic, Toronto, Ontario, Canada; Vice Chair, OMA Section of Addiction Medicine, Toronto, Ontario, Canada; Medical Director, First Step Clinics, Toronto, Ontario, Canada; Lecturer, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada; Staff, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Sankey
authors.affiliation: VP Clinical Pharmacology, INC Research, Raleigh, North Carolina.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.affiliation: Director, Biostatistics and Data Management, Purdue Pharma, Pickering, Ontario, Canada.
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Harsanyi
authors.affiliation: Retired Pharmaceutical Executive, Purdue Pharma, Pickering, Ontario, Canada.
authors.forename: Ken
authors.initials: K
authors.lastname: Michalko
authors.affiliation: Principal Biostatistician, INC Research, Raleigh, North Carolina.
authors.forename: Zejiang
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Physician, First Step Clinics; VP, INC Research, Toronto, Ontario, Canada.
authors.forename: Pierre
authors.initials: P
authors.lastname: Geoffroy
mesh_terms: D000293:Adolescent; D000328:Adult; D000701:Analgesics, Opioid / Q000737:chemistry* / Q000627:therapeutic use* / Q000652:urine; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008499:Medical Records; D008691:Methadone / Q000627:therapeutic use*; D008875:Middle Aged; D009864:Ontario; D058850:Opiate Substitution Treatment; D009293:Opioid-Related Disorders / Q000175:diagnosis / Q000534:rehabilitation* / Q000652:urine; D010098:Oxycodone / Q000737:chemistry* / Q000652:urine; D063487:Prescription Drug Misuse / Q000517:prevention & control*; D011446:Prospective Studies; D012189:Retrospective Studies; D015813:Substance Abuse Detection / Q000379:methods; D011795:Surveys and Questionnaires; D016482:Urinalysis; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone; D008691:Methadone