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

ABSTRACT:

Objective

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]).

Design

Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study.

Setting

One US site.

Subjects

Healthy, adult, nondependent, recreational opioid users.

Methods

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 p

SUBMITTER: Bond M 

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

REPOSITORIES: biostudies-literature