Trial document





This trial has been registered retrospectively.
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  DRKS00000262

Trial Description

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Title

Effects of opioid analgesics on driving ability of pain patients

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Trial Acronym

[---]*

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URL of the Trial

http://-

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Brief Summary in Lay Language

This study aims at assessing the impairing effects of long term treatment of chronic pain with opioid analgesics on traffic safety. Performance will be assessed by a computer test of driving related skills and by a driving test. This driving test is conducted in collaboration with Maastricht University on a public highway in the Netherlands.

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Brief Summary in Scientific Language

The aim of this clinical trial is to assess the impairing effects of opioid analgesics on driving ability in chronic pain patients. A group of 30 patients suffering from chronic non-malignant pain will be enrolled into the study. To meet the inclusion criteria, patients must be already treated by their attending physician by one of the following analgesics: transdermal Fentanyl, transdermal Buprenorphine, retarded Oxycodone, retarded Oxycodon (combined with Naloxone), retarded Hdromorphone, retarded Morphine, retarded Tramadol or retarded Tilidin (combined with Naloxone). There is no study related change in substance, dosage or way of administration of opioid analgesics intended. The performance of the patients will be compared to the performance of 30 matched healthy volunteers driving sober as well as under the influence of alcohol (0.5?).
Performance assessments will consist of driving tests conducted on a public highway near Maastricht (Netherlands) by the Faculty of Psychology and Neuroscience of Maastricht University and of computerized laboratory tests of driving related skills which are conducted at the pain outpatient department of the university hospital of Cologne. The driving test applied is a standardized procedure frequently used within the field of research on the impairing effects of psychoactive medical and illegal drugs. It has proven to be sensitive to drugs with sedating effects. The practical outcome of the study is to determine whether pain patients under long-term treatment are impaired in actual driving.

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Organizational Data

  •   DRKS00000262
  •   2009/12/09
  •   [---]*
  •   yes
  •   Approved
  •   09-107, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1112-5523 
  •   2009-011774-15 
  •   4035380 
  •   BASt01, version 3 of 04.11.2009  (Kennung Studienprotokoll)
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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   Patients suffering from chronic pain have to perform a compuerized test of driving related skills as well as a driving test on a primary highway. All patients are under long term treatment with opioid analgesics.
  •   Healthy controls (sober) are conducting a computerbased test of driving related skills as well as a driving test
  •   By an alcoholic beverage blood alcohol concentration of subjects is raised to 0.5 per Mille. The test of driving related skills as well as the the driving test are done by them while they are alcoholized.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

Standard deviation of lateral position (= index of weaving) assessed once || Percentage of participants which passed the computer based test of driving related skills

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/11/01
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   65   Years
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Additional Inclusion Criteria

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

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Exclusion Criteria

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

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Addresses

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    • Bundesanstalt für Straßenwesen (BASt)
    • Brüderstraße 53
    • 51427  Bergisch Gladbach
    • Germany
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    •   +49 (0)2204 43 0
    •   [---]*
    •   [---]*
    •   [---]*
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    • Bundesanstalt für Straßenwesen (BASt)
    • Mr.  Markus  Schumacher 
    • Brüderstraße 53
    • 51427  Bergisch Gladbach
    • Germany
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    • Bundesanstalt für Straßenwesen (BASt)
    • Markus  Schumacher 
    • Brüderstraße 53
    • 51427  Bergisch Gladbach
    • Germany
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Sources of Monetary or Material Support

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    • Europäisches Forschungsprojekt DRUID,DRUID = Driving under the Influence of Drugs, Alcohol and MedicinesEuropäische Kommission
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Status

  •   Recruiting complete, follow-up complete
  •   2011/05/02
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Trial Publications, Results and other Documents

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