ICADTS class III medication and fitness to drive

Establish limits for fitness to drive with prolonged use of ICADTS class III medication

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004936-31-NL

Enrollment

Unknown

Registered

2014-01-20

Start date

2014-05-28

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, anxiety, sleep disorders

Interventions

Trade Name: Xanax or generics Pharmaceutical Form: Tablet INN or Proposed INN: ALPRAZOLAM Other descriptive name: ALPRAZOLAM Concentration unit: mg milligram(s) Concentration type: range Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: chronic use of ICADTS class III medication (> 6 months) - age between 21 and 75 (inclusive) - BMI between 19 an 29 m2/kg (inclusive) - in posession of a valid drivers license for at least 3 years - driving experience of at least 3000 km/yeat on average - sufficient vision 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: - a neurological disorder - use of drugs - excessive alcohol consumption (> 21 glasses of alcohol/week) - smoking (> 10 cigarettes/day) - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the drug groups most commonly used, namely hypnotics (sleeping pills), anxiolytics, and antidepressants in therapeutic doses. The neuropsychological assessment of fitness to drive focuses on the following cognitive domains: attention and processing speed, reaction time / psychomotor functions, sensory - perceptual function, executive function and alertness / vigilance.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome measure in this study is the Standard Deviation of Lateral Position (SDLP; in cm);Timepoint(s) of evaluation of this end point: At the end (completion) of datacollection	—

Measure

Time frame

Main Objective: The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the drug groups most commonly used, namely hypnotics (sleeping pills), anxiolytics, and antidepressants in therapeutic doses. The neuropsychological assessment of fitness to drive focuses on the following cognitive domains: attention and processing speed, reaction time / psychomotor functions, sensory - perceptual function, executive function and alertness / vigilance.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome measure in this study is the Standard Deviation of Lateral Position (SDLP; in cm);Timepoint(s) of evaluation of this end point: At the end (completion) of datacollection

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome measures will be the results on the following cognitive tests: - Trailmaking A and B - Digit Symbol Substitution Test - Adaptive Tachistoscopic Traffic Perception Test - Reaction Test - Determination Test - Danger Recognition Task - Psychomotor Vigilance Task - Driving simulator tests (Swingdrive, Intersections, Merging) ;Timepoint(s) of evaluation of this end point: At the end (completion) of datacollection	—

Measure

Time frame

Secondary end point(s): The secondary outcome measures will be the results on the following cognitive tests: - Trailmaking A and B - Digit Symbol Substitution Test - Adaptive Tachistoscopic Traffic Perception Test - Reaction Test - Determination Test - Danger Recognition Task - Psychomotor Vigilance Task - Driving simulator tests (Swingdrive, Intersections, Merging) ;Timepoint(s) of evaluation of this end point: At the end (completion) of datacollection

—

Countries

Netherlands

Contacts

Public ContactProf. dr. J.G. Ramaekers

Maastricht University

j.ramaekers@maastrichtuniversity.nl00310433881951

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026