The effect of tappering off medications on driving performance and balance.

Phase 1

• Conditions: Insomnia, Anxiety, chronic pain; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-003365-99-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-29
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Possession of a valid driver's license for at least 3 years.
A driving frequency of at least once a week.
A weekly driving distance of at least 50km.
Being able to operate a manual transmission
The chronic (at least 90 days per year) use of a relevant medication (for patients only).
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

Mini Mental State Examination score of less than 24.
Deemed medically unfit to drive based on a medical screening.
Recurrent illicit or recreational drug use.
Excessive alcohol use (>21 beverages per week)
Not willing to consider discontinuation of the use of a medication of interest in case this is advised by a clinician (patients only).
The use of any psychoactive substance (control participants only)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified