Sensitivity of tests after use of benzodiazepines

Conditions: one
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-001801-42-NL

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of this study is to assess the sensitivity of a battery of tests after ingestion of different doses of two widely used benzodiazepines (i.e. diazepam 10 mg, oxazepam 10 mg, and oxazepam 30 mg) and compare it with placebo.;Secondary Objective: Secondary objective is to assess the validity of driving-related psychometric tests in predicting SDLP changes in the on-the-road driving test after ingestion of two widely used benzodiazepines (i.e. diazepam and oxazepam);Primary end point(s): The main study parameter is the Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test.;Timepoint(s) of evaluation of this end point: Evaluation of this endpoint will take place once datacollection is completed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary parameters will be accuracy and/or speed in the following tests:<br>•Psychomotor Vigilance Test (PVT)<br>•Critical tracking test (CTT)<br>•Divided Attention Test (DAT)<br>•Useful Field of View (UFOV)<br>•Digit Symbol Substition Test (DSST)<br>•Postural Balance test (PBT)<br>•Vienna Test System Determination Test (DT) <br>;Timepoint(s) of evaluation of this end point: The main study parameter is the Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test.