None
Conditions
Interventions
Trade Name: Diazepam
Pharmaceutical Form: Capsule
INN or Proposed INN: Diazepam
CAS Number: 439-14-5
Other descriptive name: DIAZEPAM
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary parameters will be accuracy and/or speed in the following tests: • Psychomotor Vigilance Test (PVT) • Critical tracking test (CTT) • Divided Attention Test (DAT) • Useful Field of View (UFOV) • Digit Symbol Substition Test (DSST) • Postural Balance test (PBT) • Vienna Test System Determination Test (DT) ;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. | — |
Countries
Netherlands
Contacts
Public ContactStefan Jongen
Maastricht University
Outcome results
None listed