Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users.

ABSTRACT: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]).Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study.One US site.Healthy, adult, nondependent, recreational opioid users.Subjects able to tolerate intranasal hydrocodone and discriminate hydrocodone from placebo were eligible for study enrollment. Eligible participants randomly received intranasal hydrocodone ER, intranasal hydrocodone powder, intranasal HYD-OF, intact oral hydrocodone ER, and placebo. Coprimary pharmacodynamic end points were a maximum effect on "at the moment" Drug Liking visual analog scale and Overall Drug Liking visual analog scale. Pharmacokinetics and safety were assessed.Mean maximum effect for "at the moment" Drug Liking was significantly (P?

SUBMITTER: Bond M 

PROVIDER: S-EPMC6084602 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other