title: Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain.
abstract: OBJECTIVE
  Evaluate aberrant drug-related behaviors in patients administering fentanyl buccal tablet or traditional short-acting opioids for breakthrough pain.
  
  
  METHODS
  Twelve-week open-label extension.
  
  
  METHODS
  Forty-two US sites.
  
  
  METHODS
  Opioid-tolerant patients with chronic pain who completed the previous randomized, double-blind, crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain.
  
  
  METHODS
  Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin any traditional short-acting opioid. Assessments included Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) at baseline and Addiction Behaviors Checklist and Current Opioid Misuse Measure at baseline and final visit. Case report forms were reviewed retrospectively to identify aberrant drug-related behaviors.
  
  
  RESULTS
  One hundred thirty patients entered the open-label extension (fentanyl buccal tablet, N = 65; traditional short-acting opioid, N = 65). SOAPP-R scores were <18 (low risk of aberrant drug-related behavior) in 74% of patients; no significant differences in SOAPP-R scores were observed between treatment groups. At the final visit, ≤14% of patients in each treatment group had scores indicating potential aberrant drug-related behavior (Addiction Behaviors Checklist ≥3, Current Opioid Misuse Measure ≥9); no significant differences in scores were observed between treatment groups. Baseline SOAPP-R score ≥18 was not predictive of Addiction Behaviors Checklist ≥3 but was predictive of Current Opioid Misuse Measure ≥9. Aberrant behaviors were identified in 12 (18%) fentanyl buccal tablet patients and 13 (20%) traditional short-acting opioid patients.
  
  
  CONCLUSIONS
  Incidence of aberrant drug-related behaviors was similar between patients taking fentanyl buccal tablet and traditional short-acting opioids over 12 weeks.
authors.affiliation: Clinical Addiction Research and Education, Millennium Research Institute, San Diego, California, USA.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Passik
authors.forename: Arvind
authors.initials: A
authors.lastname: Narayana
authors.forename: Ronghua
authors.initials: R
authors.lastname: Yang
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000278:Administration, Buccal; D000701:Analgesics, Opioid / Q000008:administration & dosage; D059390:Breakthrough Pain / Q000188:drug therapy; D059350:Chronic Pain / Q000188:drug therapy; D018592:Cross-Over Studies; D004304:Dosage Forms; D004311:Double-Blind Method; D005283:Fentanyl / Q000008:administration & dosage; D009293:Opioid-Related Disorders / Q000453:epidemiology; D010098:Oxycodone / Q000008:administration & dosage; D013607:Tablets
chemical_list: D000701:Analgesics, Opioid; D004304:Dosage Forms; D005283:Fentanyl; D010098:Oxycodone; D013607:Tablets
keywords: Aberrant Behavior; Breakthrough Pain; Chronic Pain; Fentanyl Buccal Tablet; Opioid; Risk Assessment