title: Abuse Potential with Oral Route of Administration of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users.
abstract: To compare the oral abuse potential of hydrocodone extended-release (ER) tablet developed with CIMA ® Abuse-Deterrence Technology with that of hydrocodone immediate release (IR).
  
  
  
  Randomized, double-blind, placebo-controlled, crossover study.
  
  
  
  One study site in the United States; adult nondependent, recreational opioid users.
  
  
  
  After confirming their ability to tolerate and discriminate hydrocodone IR 45 mg from placebo, eligible participants were randomized to receive each of the following oral treatments once: finely crushed placebo, hydrocodone IR 45-mg powder, intact hydrocodone ER 45-mg tablet, and finely crushed hydrocodone ER 45-mg tablet. Primary pharmacodynamic measure was "at the moment" drug liking. Secondary measures included overall drug liking, drug effects (e.g., balance, positive, negative, sedative), pupillometry, pharmacokinetics, and safety.
  
  
  
  Mean maximum effect (E max ) for "at the moment" drug liking was significantly lower for intact (53.9) and finely crushed hydrocodone ER (66.9) vs. hydrocodone IR (85.2; P  <   0.001). Drug liking for intact hydrocodone ER was comparable to placebo (E max : 53.9 vs. 53.2). Secondary measures were consistent with these results, indicating that positive, negative, and sedative drug effects were diminished with intact and crushed hydrocodone ER tablet vs. hydrocodone IR. The 72-hour plasma concentration-time profile for each treatment mimicked its respective "at the moment" drug-liking-over-time profile. Incidence of adverse events was lower with intact hydrocodone ER (53%) vs. hydrocodone IR (79%) and finely crushed hydrocodone ER (73%).
  
  
  
  The oral abuse potential of hydrocodone ER (intact and finely crushed) was significantly lower than hydrocodone IR in healthy, nondependent, recreational opioid users. Hydrocodone ER was generally well tolerated.
authors.affiliation: Department of Clinical Pharmacology (Teva), Sci-Med Bridge, LLC, Malvern, Pennsylvania, USA.
authors.forename: Mona
authors.initials: M
authors.lastname: Darwish
authors.affiliation: Departments of Clinical Pharmacology, Teva Pharmaceuticals, Frazer, PA, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Bond
authors.affiliation: Biometrics, Teva Pharmaceuticals, Frazer, Pennsylvania, USA.
authors.forename: Yuju
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Teva Pharmaceuticals, West Chester, PA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Tracewell
authors.affiliation: Global R&D, Teva Pharmaceuticals, West Chester, Pennsylvania, USA.
authors.forename: Philmore
authors.initials: P
authors.lastname: Robertson
authors.affiliation: Department of Scientific Affairs, PRA Health Sciences, Raleigh, North Carolina, USA.
authors.forename: Lynn R
authors.initials: LR
authors.lastname: Webster
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D013287:Illicit Drugs / Q000493:pharmacokinetics; D008297:Male; D009293:Opioid-Related Disorders; D011208:Powders; D013607:Tablets; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D013287:Illicit Drugs; D011208:Powders; D013607:Tablets; D006853:Hydrocodone
keywords: Abuse Potential; Drug Liking; Extended Release; Hydrocodone; Opioid Analgesics; Substance Abuse