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

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 ran...

Full description

Saved in:
Bibliographic Details
Published in:Therapeutic advances in drug safety 2015-06, Vol.6 (3), p.86-97
Main Authors: Simen, Arthur A., Gargano, Cynthia, Cha, Jang-Ho, Drexel, Melissa, Bautmans, An, Heirman, Ingeborg, Laethem, Tine, Hochadel, Thomas, Gheyle, Lien, Bleys, Kim, Beals, Chan, Stoch, Aubrey, Kay, Gary G., Struyk, Arie
Format: Article
Language:English
Subjects:
Clinical trials
Original Research
Product safety
Citations: Items that this one cites
Items that cite this one
Online Access:Request full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:2042-0986
2042-0994
DOI:10.1177/2042098615579314