Literature DB >> 26240742

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone.

Arthur A Simen1, Cynthia Gargano2, Jang-Ho Cha3, Melissa Drexel3, An Bautmans4, Ingeborg Heirman4, Tine Laethem4, Thomas Hochadel5, Lien Gheyle6, Kim Bleys6, Chan Beals3, Aubrey Stoch3, Gary G Kay5, Arie Struyk3.   

Abstract

OBJECTIVES: 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.

Entities:  

Keywords:  cognition; driving simulation; hypnotics; next-day residual drug effects; standard deviation of lane position

Year:  2015        PMID: 26240742      PMCID: PMC4519739          DOI: 10.1177/2042098615579314

Source DB:  PubMed          Journal:  Ther Adv Drug Saf        ISSN: 2042-0986


  43 in total

1.  Collision warning timing, driver distraction, and driver response to imminent rear-end collisions in a high-fidelity driving simulator.

Authors:  John D Lee; Daniel V McGehee; Timothy L Brown; Michelle L Reyes
Journal:  Hum Factors       Date:  2002       Impact factor: 2.888

2.  Is More Better? - Night Vision Enhancement System's Pedestrian Warning Modes and Older Drivers.

Authors:  Timothy Brown; Yefei He; Cheryl Roe; Thomas Schnell
Journal:  Ann Adv Automot Med       Date:  2010

3.  Driving simulator for speed research on two-lane rural roads.

Authors:  Francesco Bella
Journal:  Accid Anal Prev       Date:  2007-12-26

4.  The acute effects of 3,4-methylenedioxymethamphetamine and methamphetamine on driving: a simulator study.

Authors:  Con Stough; Luke A Downey; Rebecca King; Katherine Papafotiou; Phillip Swann; Edward Ogden
Journal:  Accid Anal Prev       Date:  2011-09-19

5.  MDMA and alcohol effects, combined and alone, on objective and subjective measures of actual driving performance and psychomotor function.

Authors:  K P C Kuypers; N Samyn; J G Ramaekers
Journal:  Psychopharmacology (Berl)       Date:  2006-07-08       Impact factor: 4.530

6.  Driving simulator performance in patients with possible and probable Alzheimer's disease.

Authors:  Anthony C Stein; Richard M Dubinsky
Journal:  Ann Adv Automot Med       Date:  2011

Review 7.  Zopiclone as positive control in studies examining the residual effects of hypnotic drugs on driving ability.

Authors:  Joris C Verster; D Warren Spence; Azmeh Shahid; Seithikurippu R Pandi-Perumal; Thomas Roth
Journal:  Curr Drug Saf       Date:  2011-09-01

8.  Effects of two doses of methylphenidate on simulator driving performance in adults with attention deficit hyperactivity disorder.

Authors:  Russell A Barkley; Kevin R Murphy; Trisha O'Connell; Daniel F Connor
Journal:  J Safety Res       Date:  2005-04-18

9.  Residual effects of zopiclone and benzodiazepine hypnotics on psychomotor performance related to car driving.

Authors:  C Harrison; Z Subhan; I Hindmarch
Journal:  Drugs Exp Clin Res       Date:  1985

10.  Standard operation procedures for conducting the on-the-road driving test, and measurement of the standard deviation of lateral position (SDLP).

Authors:  Joris C Verster; Thomas Roth
Journal:  Int J Gen Med       Date:  2011-05-17
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  7 in total

1.  Validity and reliability of a driving simulator for evaluating the influence of medicinal drugs on driving performance.

Authors:  Mari Iwata; Kunihiro Iwamoto; Iwao Kitajima; Takasuke Nogi; Koichi Onishi; Yu Kajiyama; Izumi Nishino; Masahiko Ando; Norio Ozaki
Journal:  Psychopharmacology (Berl)       Date:  2020-11-24       Impact factor: 4.530

2.  Simulated driving performance in healthy adults after night-time administration of 20 mg tasimelteon.

Authors:  Rosarelis Torres; Michaela Fisher; Gunther Birznieks; Christos Polymeropoulos; Gary G Kay; Changfu Xiao; Mihael H Polymeropoulos
Journal:  J Sleep Res       Date:  2021-06-21       Impact factor: 5.296

3.  Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.

Authors:  Eric M Pearlman; Darren Wilbraham; Ellen B Dennehy; Paul H Berg; Max Tsai; Erin G Doty; Gary G Kay
Journal:  Hum Psychopharmacol       Date:  2020-05-25       Impact factor: 1.672

4.  Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator.

Authors:  Clemens Muehlan; Sander Brooks; Cedric Vaillant; Michael Meinel; Gabriël E Jacobs; Rob G Zuiker; Jasper Dingemanse
Journal:  Clin Pharmacol Ther       Date:  2022-04-20       Impact factor: 6.903

5.  Next-day residual effects of flibanserin on simulated driving performance in premenopausal women.

Authors:  Gary G Kay; Thomas Hochadel; Eric Sicard; Karthi K Natarajan; Noel N Kim
Journal:  Hum Psychopharmacol       Date:  2017-05-31       Impact factor: 1.672

6.  An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine.

Authors:  Judy Caron; Randall Kaye; Thomas Wessel; Amy Halseth; Gary Kay
Journal:  J Clin Pharm Ther       Date:  2020-05-10       Impact factor: 2.512

7.  A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance.

Authors:  Shengfang Su; Gary Kay; Thomas Hochadel; Jonathan Rojo; J Christopher Stein; Ramesh Boinpally; Antonia Periclou
Journal:  Clin Transl Sci       Date:  2021-11-07       Impact factor: 4.689

  7 in total

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