Comparison of Subjective Effects of Extended-Release Versus Immediate-Release Oxycodone/Acetaminophen Tablets in Healthy Nondependent Recreational Users of Prescription Opioids: A Randomized Trial

Abstract

This phase 1 study conducted in the United States was not registered.

Human abuse potential of immediate-release/extended-release versus immediate-release hydrocodone bitartrate/acetaminophen: a randomized controlled trial in recreational users of prescription opioids

“…IR/ER OC/APAP had lower and delayed positive subjective effects compared with IR OC/ APAP, in equal and single doses of intact and crushed tablets [12]. Moreover, crushed IR/ER OC/APAP tablets produced lower and delayed positive subjective effects compared with intact IR/ER OC/APAP tablets [12]. A limitation of this trial and the current study is the assumption that encapsulation of the crushed tablets would not meaningfully affect the absorption or subjective effects of the study drugs.…”

“…IR/ER OC/APAP had lower and delayed positive subjective effects compared with IR OC/ APAP, in equal and single doses of intact and crushed tablets [12]. Moreover, crushed IR/ER OC/APAP tablets produced lower and delayed positive subjective effects compared with intact IR/ER OC/APAP tablets [12].…”

“…Human abuse potential (HAP) studies assess an opioid analgesic on physiologic, subjective, and observational measures in volunteer participants under controlled, laboratory conditions to predict the likelihood that the medication will be abused after it is marketed [10]. HAP studies have been used to assess the abuse potential of many drugs, not only those with an abuse-deterrent design [11][12][13][14][15][16][17][18].…”

Evaluation of the tamper-resistant properties of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets

“…Previous research in recreational abusers of prescription opioids has demonstrated that IR/ER OC/APAP tablets have lower attractiveness for abuse compared with IR OC/APAP tablets, crushed or intact, in single, equal, orally administered doses, based on positive subjective effects 17 . Importantly, this study assessed the ease with which IR/ER OC/APAP tablets can be tampered to facilitate snorting and injection because its comparator (IR OC/APAP) is abused by these means, although more commonly through oral intake of intact tablets.…”

“…In a recent study of recreational users of prescription opioids, IR/ER OC/APAP tablets were found to be less attractive for abuse compared with IR OC/APAP tablets on the basis of positive subjective drug effects when administered orally as single, equal doses, in intact and crushed states 17 .…”