Open AccessA Randomized, Rater‐Blinded, Crossover Study of the Effects of Oxymorphone Extended Release, Fed versus Fasting, on Cognitive Performance as Tested with CANTAB in Opioid‐Tolerant Subjects
Author(s) -
Spierings Egilius L. H.,
Volkerts Edmund R.,
Heitland Ivo,
Thomson Heather
Publication year - 2014
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/pme.12307
Subject(s) - oxymorphone , crossover study , cambridge neuropsychological test automated battery , medicine , meal , area under the curve , effects of sleep deprivation on cognitive performance , anesthesia , cmax , postprandial , opioid , endocrinology , working memory , cognition , pharmacokinetics , spatial memory , psychiatry , oxycodone , receptor , alternative medicine , pathology , placebo , insulin
Abstract Background The maximum plasma concentration ( C max ) of oxymorphone extended release ( ER ) 20 mg and 40 mg is approximately 50% higher in fed than in fasted subjects, with most of the difference in area‐under‐the‐curve ( AUC ) occurring in the first 4 hours post‐dose. Hence, the US FDA recommends in the approved labeling that oxymorphone ER is taken at least 1 hour before or 2 hours after eating. Methods In order to determine the potential impact on cognitive performance of the increased absorption of oxymorphone ER , fed versus fasting, we conducted a randomized, rater‐blinded, crossover study in 30 opioid‐tolerant subjects, using tests from the C ambridge N europsychological T est A utomated B attery ( CANTAB ). The subjects randomly received 40 mg oxymorphone ER after a high‐fat meal of approximately 1,010 kCal or after fasting for 8–12 hours, and were tested 1 hour and 3 hours post‐dose. Results The CANTAB tests, S patial R ecognition M emory ( SRM ) and S patial W orking M emory ( SWM ), showed no statistically significant differences between the fed and fasting conditions. However, sustained attention, as measured by the R apid V isual I nformation P rocessing ( RVP ) CANTAB test, showed a statistically significant interaction of fed versus fasting and post‐dose time of testing ( F [1,28] = 6.88, P = 0.01), suggesting that 40 mg oxymorphone ER after a high‐fat meal versus fasting mitigates the learning effect in this particular cognition domain from 1 hour to 3 hours post‐dose. Conclusion Oxymorphone 40 mg ER affected cognitive performance similarly within 3 hours post‐dose, whether given on an empty stomach or after a high‐fat meal, suggesting that the effect of food on plasma concentration may not be relevant in the medication's impact on cognition.