Journal of opioid management
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Randomized Controlled Trial
A nasal abuse potential randomized clinical trial of REMOXY® ER, a high-viscosity extended-release oxycodone formulation.
This study examined the nasal abuse deterrence of REMOXY ER, a novel high-viscosity extended-release oxycodone formulation. ⋯ Abuse-deterrent drugs are intended to help fight opioid abuse. Yet the persistence of the opioid epidemic indicates that vast improvements in abuse-deterrent technology are needed. A new, high-viscosity, extended-release oxycodone formulation showed robust abuse-deterrence against the nasal route of abuse in an Food and Drug Administration-advised clinical trial in recreational opioid users.
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Randomized Controlled Trial Comparative Study
Evaluation of the oral human abuse potential of Oxycodone DETERx® formulation (Xtampza® ER).
To further characterize the human abuse potential and pharmacokinetics (PK) of Oxycodone DETERx (Xtampza® ER) after intact and chewed oral administration. ⋯ This study showed that when chewed or swallowed intact, under fasted or fed conditions, Oxycodone DETERx had statistically significantly lower abuse potential via the oral route compared with IR oxycodone.
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Randomized Controlled Trial
The impact of preinduction fentanyl dosing strategy on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Postoperative nausea and vomiting (PONV) is commonly attributed to opioid analgesics; consequently, perioperative opioid dosage reduction is a common practice. However, inadequate fentanyl analgesia may have adverse implications (sympathetic activation, pain). We conducted this randomized clinical study to analyze whether preinduction fentanyl 3 µg kg-1 administered by different techniques increases incidence of PONV. ⋯ Controlled administration of preinduction fentanyl 3 µg kg-1 by commonly employed administration methods does not seem to impact PONV profile. Further studies are needed to establish a temporal link between preinduction fentanyl and PONV.
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Randomized Controlled Trial
Efficacy and safety of naloxegol for opioid-induced constipation assessed by specific opioid medication, opioid dose, and duration of opioid use.
Efficacy and safety of naloxegol, a peripherally acting µ-opioid receptor antagonist that significantly reduces opioid-induced constipation (OIC), were assessed for patient subgroups defined post hoc by baseline maintenance opioid characteristics. ⋯ In this post hoc, exploratory analysis, naloxegol 25 mg showed similar efficacy in treating OIC regardless of maintenance opioid type, dose, or duration of opioid use at baseline.
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Randomized Controlled Trial Comparative Study
Intranasal abuse potential of an abuse-deterrent oxycodone formulation compared to oxycodone immediate release and placebo in nondependent, recreational opioid users.
To assess the intranasal (IN) human abuse potential of ELI-200, a novel immediate-release (IR) oxycodone formulation containing sequestered naltrexone. ⋯ IN administration of ELI-200 demonstrated significantly decreased effects on subjective and physiologic measures, and greater nasal irritation, compared to IN oxycodone IR. These findings, along with the PK profile of naltrexone, demonstrated that when ELI-200 capsules were ground and administered intranasally, the naltrexone component was rapidly released and conferred meaningful abuse-deterrent properties.