TY  - JOUR
PY  - 2016//
TI  - Abuse potential with oral route of administration of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in nondependent, recreational opioid users
JO  - Pain medicine
A1  - Darwish, Mona
A1  - Bond, Mary
A1  - Ma, Yuju
A1  - Tracewell, William
A1  - Robertson, Philmore
A1  - Webster, Lynn R.
SP  - 61
EP  - 77
VL  - 18
IS  - 1
N2  - 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). <br><br>DESIGN: Randomized, double-blind, placebo-controlled, crossover study. SETTING AND PATIENTS: One study site in the United States; adult nondependent, recreational opioid users. <br><br>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. <br><br>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%). <br><br>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.<br><br>© 2016 American Academy of Pain Medicine.<p />  <p>Language: en</p>
LA  - en
SN  - 1526-2375
UR  - http://dx.doi.org/10.1093/pm/pnw122
ID  - ref1
ER  -