Sensitivity of driving-related psychometric tests to the effects of two widely prescribed benzodiazepines: diazepam and oxazepam

Maastricht University0 个研究点开始时间: 2014年7月24日最近更新: 2016年4月11日

适应症

试验速览

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•-healthy males or females, in the opinion of the medical supervisor, based on a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood chemistry, haematology, and serology tests, and urinalysis
•-aged between 23 and 50 years (inclusive)
•-BMI between 19 and 29 m2/kg (inclusive)
•-Possession of a valid driving license for 4 years or more
•-Driving experience of at least 3000 km per year on average
•-Good sleepers
•-Subjects should sign an Informed Consent Form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-history of mental illness
•-Sleep disorders such as insomnia and narcolepsy.
•-history of or current drug or alcohol abuse
•-current use of psycho-active medication, and inability to stay abstinent during the study
•-excessive alcohol use, defined as drinking more than 21 glasses of alcohol per week.
•-excessive caffeine use, defined as drinking 5 or more cups of coffee per day
•-Smoking more than 10 cigarettes per day

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