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- W2023261154 abstract "Increased non-medical use of prescription opioids has created a need for opioid products with reduced abuse potential. Oxycodone HCl/niacin tablets combine oxycodone with niacin and functional inactive excipients to provide limits and impediments to intentional oral overconsumption and intranasal and intravenous abuse. This randomized, double-blind, placebo- and active-controlled, 5-way crossover study compared the relative abuse potential of orally-administered immediate-release (IR) oxycodone HCl/niacin tablets to dose-equivalent IR oxycodone HCl tablets in 49 non-dependent recreational opioid users. Dose-response was also assessed. Subjects received: oxycodone/niacin-40/240mg, oxycodone/niacin-80/480mg, oxycodone-40mg, oxycodone-80mg, and placebo. Primary endpoint was Drug-Liking (bipolar visual analog scale [VAS]; 0=dislike an awful lot, 50=neither like nor dislike, 100=like an awful lot), assessed by area under effect curve (AUE0-1h, AUE0-2h, AUE0-3h), peak disliking effect (Emin), and effect at 0.5h post-dose (E0.5h). Other assessments included peak-liking effect (Emax), Take Drug Again Assessment (TDAA), and Overall Drug Liking (ODL); bipolar 100-point VAS for TDAA and ODL. There were significant differences between oxycodone/niacin and dose-corresponding IR oxycodone for Drug-Liking AUE0-1h, AUE0-2h, AUE0-3h, Emin, and E0.5h (p<0.0001, all comparisons) and for Emax (oxycodone/niacin-40/240mg, p=0.004; oxycodone/niacin-80/480mg, p<0.0001). Oxycodone/niacin-80/480mg was less liked than oxycodone/niacin-40/240mg, suggesting dose-response. Mean (SD) Drug-Liking scores for oxycodone/niacin-40/240mg and oxycodone/niacin-80/480mg were 47.0(20.3) and 40.1(23.4) at 0.5h, while scores for oxycodone-40mg and oxycodone-80mg were 66.0(16.3) and 74.8(16.7) (p<0.0001). TDAA and ODL also showed significant differences with greater liking of oxycodone without niacin compared to equivalent oxycodone with niacin. Adverse events (AEs) were consistent with known effects of oxycodone and niacin; most were mild or moderate in intensity. No serious AEs occurred. Results suggest that abuse potential of oxycodone/niacin tablets may be decreased compared with equivalent doses of IR oxycodone HCl in non-dependent recreational opioid users. Drug-Liking decreased with increased niacin dose. Early effects of overconsumption of oxycodone/niacin tablets may decrease abuse potential. Supported by King Pharmaceuticals®, Inc." @default.
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- W2023261154 date "2011-04-01" @default.
- W2023261154 modified "2023-09-26" @default.
- W2023261154 title "Oxycodone HCl/niacin tablets may reduce abuse potential vs dose-equivalent oxycodone HCl in non-dependent recreational opioid users" @default.
- W2023261154 doi "https://doi.org/10.1016/j.jpain.2011.02.278" @default.
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