Citation

Darwish M, Bond M, Ma Y, Tracewell W, Robertson P, Webster LR. Pain Med. 2016; 18(1): 61-77.

Affiliation

Department of Scientific Affairs, PRA Health Sciences, Raleigh, North Carolina, USA.

Copyright

(Copyright © 2016, Oxford University Press)

DOI

10.1093/pm/pnw122

PMID

27330154

Abstract

OBJECTIVE: 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).

DESIGN: Randomized, double-blind, placebo-controlled, crossover study. SETTING AND PATIENTS: One study site in the United States; adult nondependent, recreational opioid users.

METHODS: 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.

RESULTS: Mean maximum effect (Emax) 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 (Emax: 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%).

CONCLUSIONS: 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.

© 2016 American Academy of Pain Medicine.

Language: en