Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers

British Journal of Clinical Pharmacology
Nathalie ProssNicolas Fauchoux

Abstract

The pharmacologic effects of sodium oxybate (SO) have a number of similarities with those of alcohol. This study evaluated the pharmacodynamic interaction of SMO.IR (a solid immediate release formulation of SO) and alcohol (0.7 (males) or 0.57 (females) g kg(-1) alcohol using 40% vodka). In a randomized, double-blind, double-dummy, crossover trial, 24 healthy volunteers received randomly a) 2.25 g SMO.IR and placebo alcohol preparation, b) 2.25 g f SMO.IR and alcohol, c) 2.25 g SMO.IR matching placebo and alcohol and d) 2.25 g of SMO.IR matching placebo and placebo alcohol preparation. Objective and subjective cognitive parameters, adverse events and vital signs were assessed before, 15 and 165 min after treatment administration. Alcohol produced the expected cognitive impairment and the expected subjective sedation rapidly after intake (from 15 min). The objective effects of SMO.IR were much less pronounced than those of alcohol. The reverse was observed for subjective complaints, which were related to lesser stimulation and greater sedation. Nevertheless, 165 min after administration this sedation feeling was less with SMO.IR than with alcohol. There was a significant interaction between SMO.IR and alcohol at 15 min (i.e. inc...Continue Reading

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Jan 8, 2016·Medicinal Research Reviews·Michel MaitreAyikoe G Mensah-Nyagan
Mar 10, 2016·International Journal of Environmental Research and Public Health·Fabio CaputoGiovanni Addolorato
Feb 11, 2016·Journal of Psychopharmacology·Fabio CaputoMauro Bernardi

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