title: A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone.
abstract: OBJECTIVE
  We sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.
  
  
  METHODS
  A total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.
  
  
  RESULTS
  Evening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.
  
  
  CONCLUSIONS
  Further validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies.
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA 19454, USA. Present address: Pfizer Worldwide Research & Development, Cambridge, MA 02139, USA.
authors.forename: Arthur A
authors.initials: AA
authors.lastname: Simen
authors.affiliation: Johnson & Johnson, Springhouse, PA 19477.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Gargano
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
authors.forename: Jang-Ho
authors.initials: JH
authors.lastname: Cha
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Drexel
authors.affiliation: Merck ESD EU, MSD Europe Inc., Belgium.
authors.forename: An
authors.initials: A
authors.lastname: Bautmans
authors.affiliation: Merck ESD EU, MSD Europe Inc., Belgium.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Heirman
authors.affiliation: Merck ESD EU, MSD Europe Inc., Belgium.
authors.forename: Tine
authors.initials: T
authors.lastname: Laethem
authors.affiliation: Cognitive Research Corporation, Saint Petersburg, FL, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hochadel
authors.affiliation: SGS Life Science Services, Antwerp, Belgium.
authors.forename: Lien
authors.initials: L
authors.lastname: Gheyle
authors.affiliation: SGS Life Science Services, Antwerp, Belgium.
authors.forename: Kim
authors.initials: K
authors.lastname: Bleys
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
authors.forename: Chan
authors.initials: C
authors.lastname: Beals
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
authors.forename: Aubrey
authors.initials: A
authors.lastname: Stoch
authors.affiliation: Cognitive Research Corporation, Saint Petersburg, FL, USA.
authors.forename: Gary G
authors.initials: GG
authors.lastname: Kay
authors.affiliation: Merck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
authors.forename: Arie
authors.initials: A
authors.lastname: Struyk
keywords: cognition; driving simulation; hypnotics; next-day residual drug effects; standard deviation of lane position