title: Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials.
abstract: OBJECTIVE
  The aim of this study was to compare the effects of concomitant administration of alcohol and bilastine versus alcohol alone on the central nervous system.
  
  
  METHODS
  Twenty-four healthy young volunteers of both sexes participated in a randomized, double-blind, double-dummy, crossover, and positive-controlled and placebo-controlled clinical trials. At 1-week intervals, subjects received six different treatments: (i) placebo; (ii) alcohol 0.8 g/kg alone (ALC); (iii) ALC in combination with: bilastine 20 mg (B20 + A); (iv) bilastine 80 mg (B80 + A); (v) cetirizine 10 mg (CET + A); and (vi) hydroxyzine 25 mg (HYD + A). Psychomotor performance tests (fine motor, finger tapping, nystagmus, critical flicker-fusion frequency, temporal estimation, 'd2' cancellation, and simple reaction time) and subjective self-reports (drunkenness, drowsiness, mental slowness, clumsiness, anger, attentiveness, competence, happiness, hostility, interest, and extroversion) were carried out at baseline and multiple points thereafter.
  
  
  RESULTS
  All active treatments induced a significant psychomotor impairment. The greatest and most lasting impairment was observed with HYD + A followed by B80 + A and CET + A. In contrast, objective measures showed less impairment with B20 + A and ALC, both with a similar magnitude. Self-reports showed a subjective perception of performance impairment in all active treatments.
  
  
  CONCLUSIONS
  Concomitant administration of bilastine (at therapeutic dose) and alcohol does not produce greater central nervous system depressant effects than ACL alone.
authors.affiliation: Centre d'Investigació de Medicaments (CIM), Institut de Investigacions Biomèdiques (IIB), Institut de Recerca (IR); Servei de Farmacologia Clínica, Hospital de la Santa Creu i Sant Pau (HSCSP), Barcelona, Spain; Departament de Farmacologia i Terapèutica, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Consuelo
authors.initials: C
authors.lastname: García-Gea
authors.forename: Joan
authors.initials: J
authors.lastname: Martínez
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Ballester
authors.forename: Ignasi
authors.initials: I
authors.lastname: Gich
authors.forename: Román
authors.initials: R
authors.lastname: Valiente
authors.forename: Rosa Maria
authors.initials: RM
authors.lastname: Antonijoan
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects; D000428:Alcohol Drinking; D001562:Benzimidazoles / Q000009:adverse effects / Q000494:pharmacology*; D002492:Central Nervous System Depressants / Q000009:adverse effects / Q000494:pharmacology*; D017332:Cetirizine / Q000009:adverse effects / Q000494:pharmacology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004347:Drug Interactions; D000431:Ethanol / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006633:Histamine Antagonists / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D010880:Piperidines / Q000009:adverse effects / Q000494:pharmacology*; D011597:Psychomotor Performance / Q000187:drug effects; D012737:Sex Factors; D055815:Young Adult
chemical_list: D001562:Benzimidazoles; D002492:Central Nervous System Depressants; D006633:Histamine Antagonists; D010880:Piperidines; D006919:Hydroxyzine; D000431:Ethanol; C445659:bilastine; D017332:Cetirizine
keywords: CNS effects; alcohol; bilastine; cetirizine; healthy volunteers; hydroxizyne