Effects of opioid analgesics on driving ability of pain patients[Untersuchung zur Fahrsicherheit von Schmerzpatienten]

• Conditions: patients suffering from chronic non-cancer pain responsive to opioid analgesics under already existing long-term treatment; MedDRA version: 11.0Level: LLTClassification code 10067033Term: <Manually entered code. Term in E.1.1>; MedDRA version: 9.1Level: LLTClassification code 10013496Term: Disturbance in attention; MedDRA version: 9.1Level: HLTClassification code 10027375Term: Mental impairment (excl dementia and memory loss)

• Registration Number: EUCTR2009-011774-15-DE
• Lead Sponsor: Federal Highway Research Institute / Bundesanstalt für Straßenwesen (BASt)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Written informed consent.
2) Age: = 30 = 65: as far as possible three groups are built consisting of 10 persons each: 30-39, 40-49, 50-65.
3) Stable social background
4) Body weight within 16-30 according to body mass index (BMI)
5) Normal blood pressure and normal heart rate at rest
6) Vision normal or corrected to normal
7) Valid driver’s license for passenger cars
8) Kilometres travelled per year: at least 2.000 km per year during preceding 12 month
9) Driving on a regular basis: at least once per week
10) Ability to drive a passenger car with manual transmission
11) Chronic non-cancer pain responsive to opioid analgesics
12) 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®)
13) No dose change within the preceding 14 days
14) Dosage at least at
•12 µg/h transdermal Fentanyl
•35µg/h transdermal Buprenorphine
•2x5mg Oxycodone.
15) Co-medication with NSAID and/or anticonvulsants and/or antidepressants on a stable dose within the preceding 14 days

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects who fail to meet any of the inclusion criteria
2) Persons who are imprisoned or are detained in a health mental institution by court or official order
3) Malignant disease
4) Severe disabilities that are expected to interfere with computerized testing or car driving
5) Women who are pregnant or breast feeding or women of child-bearing potential who are not using a highly effective contraception method with a pearl-index <=1.
6) Expected inability to drive the experimental car 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.
7) 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
8) Subjects with alcohol or drug abuse or dependency
9) 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)
10) Excessive smokers (more than 20 cigarettes a day) or excessive drinkers (more than 28 glasses of alcohol containing beverages per week)
11) Regular intake of Benzodiazepines (= 4 times per week)
12) Intake of Benzodiazepines within 2 days before assessment days
13) Regular intake of barbiturates (> 3 times per week) as well as intake of barbiturates within 2 days before the assessment days
14) 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)
15) Daily intake of anticonvulsant in higher dosage (Carbamazepin > 1200mg, Oxcarbazepin >1800mg, Gabapentin >2400mg, Pregabalin >600mg)
16) Intake of MAO inhibitors
17) Regular intake of un-retarded opioids oder intake of un-retarded opioids within 2 days prior to assessment days
18) Regular intake of antihistamines
19) Inability to communicate meaningfully with the study staff (insufficient language skills)
20) Treatment with the combination of naloxone and Oxycodone (e.g. Targin®)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess driving ability by a standardized on-the-road driving test and by a standardized computerized test of driving related skills of chronic pain patients under long term treatment with opioid analgesics. Performance of patients is compared to performance of matched healthy controls sober and alcoholized (BAC = 0.50 g/L);Secondary Objective: Correlation between performance in driving test and computerized test of driving related skills;Primary end point(s): Driving test: <br>- Standard deviation of lateral position (SDLP;a measure of road tracking error, in practical terms, a composite index of allowed weaving, swerving and overcorrecting)<br>- Time to Speed Adaptation while following a car which changes speed<br>- Brake reaktion time <br>Computerized test of driving related skills:<br>An overall score is calculated by z-transformed values of all test scores of the computerized test battery