Insomnia, Anxiety, chronic pain
Conditions
Interventions
Trade Name: all available benzodiazepines, z-hypnotics, opioids
Product Name: Benzodiazepines, z-hypnotics, opioids
Pharmaceutical Form: Capsule, hard
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is primarily to investigate the effects of a withdrawal intervention on measures of driving performance in a clinical population that uses benzodiazepines, Z-hypnotics, or opioid analgesics chronically. ;Secondary Objective: As a secondary objective, this study also aims to replicate previous findings that demonstrate that fall risk decreases after cessation of psychoactive medications by observing the effects of cessation on measures of postural balance.;Primary end point(s): The main outcome parameter of the study will be the standard deviation of the lateral position (SDLP) of the test vehicle during a standardized on-the-road driving test.;Timepoint(s) of evaluation of this end point: Once before and once after cessation of the relevant medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Furthermore, a neurocognitive test battery consisting of neuropsychological tests and laboratory computer tasks will be used. Also, a driving simulator test will be included. For our secondary objective, a postural balance task is included which measures body sway.;Timepoint(s) of evaluation of this end point: Once before and once after cessation of the relevant medication | — |
Countries
Belgium, Netherlands
Contacts
Public ContactJan Ramaekers
Maastricht University
Outcome results
None listed