Effects of opioid analgesics on driving ability of pain patients
- Conditions
- F45.41
- Registration Number
- DRKS00000262
- Lead Sponsor
- Bundesanstalt für Straßenwesen (BASt)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
Written informed consent.
Age: 30-65
Body weight within 16-35 according to body mass index (BMI)
Vision normal or corrected to normal
Valid driverlicense for passenger cars.
Kilometres travelled per year: at least 2.000 km per year during preceding 12 month
Driving on a regular basis: at least once per week
Ability to drive a passenger car with manual transmission
Chronic non-cancer pain responsive to opioid analgesics
Treatment for at least four weeks with
- transdermal Fentanyl (e.g. Durogesic Smat®) & or
- transdermal Buprenorphine (e.g. Transtec®) or
- retarded Oxycodone (e.g. Oxygesic®) or
- retarded Oxycodone combined with Naloxone (z.B. Targin ®)
- retarded Hydromorphone (z.B. Palladon®, Jurnista®)
- retarded Morphine (z.B. MST®)
- retarded Tramadol (z.B. Tramal long®)
- retarded Tilidin combined with Naloxone (z.B. Valoron N ®)
- No dose change within the preceding 14 days
- Co-medication with NSAID and/or anticonvulsants and/or antidepressants on a stable dose within the preceding 14 days
Subjects who fail to meet any of the inclusion criteria
Persons who are imprisoned or are detained in a health mental institution by court or official order
Malignant disease
Severe disabilities that are expected to interfere with computerized testing or car driving
Expected inability to drive the experimental car safely or to complete computerized testing or endangerment of being overstrained during the driving test or during computerized testing according to the estimation of the physician accomplishing the medical check up.
Psychological or psychiatric disorders or severe physical disorders (history or current evidence of severe physical or mental disorders, serious gastrointestinal, hepatic, renal, cardiovascular or neurological disorders or severe allergies) that may interfere with participation in computerized testing or driving test
Subjects with alcohol or drug abuse or dependency
Unwillingness or inability to abstain from consumption of alcohol, psychoactive medication or drugs within 24 hours prior to the assessment day (urine drug screening, alcohol breath analyzer)
Excessive drinkers (more than 28 glasses of alcohol containing beverages per week)
Inability or unwillingness to abstain from smoking for the duration of the driving test or the computer based test
Regular intake of Benzodiazepines (> 4 times per week)
Intake of Benzodiazepines within 2 days before assessment days
Regular intake of barbiturates (> 3 times per week) as well as intake of barbiturates within 2 days before the assessment days
Daily intake of antidepressants in higher dosage (Amitryptilin > 75mg, Doxepin > 75mg, Imipramin > 75mg, Trazodon > 100mg, Sertralin > 50mg, Fluoxetin > 20mg, Fluvoxamin >75mg, Duloxetin > 120mg, Venlafaxin > 225mg, Citalopram > 10mg)
Daily intake of anticonvulsant in higher dosage (Carbamazepin > 1200mg, Oxcarbazepin >1800mg, Gabapentin >2400mg, Pregabalin >600mg)
Intake of MAO inhibitors
Regular intake of un-retarded opioids (> 7 times per week) or intake of un-retarded opioids within 2 days prior to assessment and on the assessment days
Regular intake of antihistamines
Inability to communicate meaningfully with the study staff (insufficient language skills)
Participation in another study within 30 days before enrolment to this study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standard deviation of lateral position (= index of weaving) assessed once || Percentage of participants which passed the computer based test of driving related skills
- Secondary Outcome Measures
Name Time Method