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

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.

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

Conflict of interest statement

Conflict of interest statement: T.H. and G.G.K. have a financial interest in Cognitive Research Corporation, the company that developed and markets the Mini-Sim. The remaining authors have no conflicts of interest to declare in preparing this article.

Figures

Figure 1.

SDLP versus treatment. SDLP is shown plotted as a function of treatment condition, with lines connecting data values from individual subjects. Subjects with higher SDLP in the zopiclone condition are plotted in grey and subjects with lower SDLP in the zopiclone condition are plotted in black. SDLP was higher in the zopiclone condition than in the placebo condition. See Table 2 for statistical results.

Figure 2.

Symbol digit coding (SDC) versus treatment. SDC is shown plotted as a function of treatment condition, with lines connecting data values from individual subjects. Subjects with higher SDC performance in the zopiclone condition are plotted in grey, and subjects with lower SDC performance in the zopiclone condition are plotted in black. On average, zopiclone cause a worsening of performance on SDC. See Table 3 for statistical results.