title: Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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. increase in alertness and stimulation and decrease in sedation). In addition, an isolated mild decrease in digit vigilance accuracy occurred at 165 min post-dose after the combination. The co-administration of SMO.IR and alcohol was safe and well-tolerated.
  
  
  CONCLUSIONS
  SMO.IR and alcohol have distinct adverse effect profiles. The objective effects of SMO.IR are much less marked than those of alcohol. No deleterious interaction was observed.
authors.affiliation: BIOTRIAL, Neuroscience, 6 Avenue de Bruxelles, 68350, Didenheim, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Pross
authors.affiliation: BIOTRIAL, 7-9 rue Jean-Louis Bertrand, 35042, Rennes, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Patat
authors.affiliation: D&A PHARMA, 7-9 rue de Miromesnil, 75008, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Vivet
authors.affiliation: BIOTRIAL, 7-9 rue Jean-Louis Bertrand, 35042, Rennes, France.
authors.forename: Michelle
authors.initials: M
authors.lastname: Bidaut
authors.affiliation: BIOTRIAL, 7-9 rue Jean-Louis Bertrand, 35042, Rennes, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Fauchoux
mesh_terms: D000293:Adolescent; D000328:Adult; D001288:Attention / Q000187:drug effects*; D003072:Cognition Disorders / Q000139:chemically induced*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D065546:Drug Liberation; D000431:Ethanol / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D005133:Eye Movements / Q000187:drug effects*; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D010775:Photic Stimulation; D004856:Postural Balance / Q000187:drug effects*; D012978:Sodium Oxybate / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: D000431:Ethanol; D012978:Sodium Oxybate
keywords: CNS effects; drug interaction; ethanol; healthy subjects; sodium oxybate