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Driving Ability of Drug Dependant Patients in Maintenance Therapy

This study has been completed.
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
Hummel, Christiane
ClinicalTrials.gov Identifier:
NCT01150435
First received: June 23, 2010
Last updated: June 24, 2010
Last verified: June 2010
History of Changes

June 23, 2010
June 24, 2010
February 2008
April 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01150435 on ClinicalTrials.gov Archive Site
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Driving Ability of Drug Dependant Patients in Maintenance Therapy
Driving Ability of Drug Dependant Patients in Maintenance Therapy

"Mobility" is a contributing factor in today's society. Drug dependence displays not only a medical but also an economic problem: Especially for an intended reintegration of a drug dependant patient in maintenance therapy the possession of a driving licence could be decisive for a job allocation and therefore the intended reintegration to society.

Subject of this study was to verify if patients under substitution therapy with R, S- Methadone, S- Methadone, Buprenorphine and Buprenorphine plus Naloxone are just as fit to drive a car as a non drug dependent person.

For this investigation we compared 121 drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC) with non- drug dependant subjects of the same gender, age and level of education.

This is the largest study on this topic worldwide. The neuro- cognitive working order was tested by means of the "Vienna Test System" an objective, reliable and valid test quantifying reaction time, attention efficiency, concentration, maximum resilience and orientation. Current use of any other psychotropic substance or alcohol just as any serious illness (including psychiatric diseases, except for an effectively treated depression) lead to exclusion from this study.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Drug screen Urin
Non-Probability Sample

drug dependent patients in stable maintenance therapy
Driving Ability
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  • Maintenance Medication D, S- Methadon
  • Maintenance Medication S- Methadon
  • Buprenorphine
  • Buprenorphine+ Naloxone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
June 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Drug dependent patients in stable maintenance therapy for a minimum of two years without consumption of any other psychotropic substances than their maintenance drug (including THC)
  • Written agreement on attending this study after full clarification
  • majority

Exclusion Criteria:

  • Patients, who do not approve or are not able to approve, to this study
  • Patients, who are not legally competent
  • Patients in emergency situations
  • Patients under age
  • Consumption of any other psychotropic substances than the maintenance drug
  • Severe illnesses p.e. malignant diseases, serious psychiatric illness
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01150435
Hummel 2010-1
No
Christiane Hummel
Hummel, Christiane
Ludwig-Maximilians - University of Munich
Study Director: Thomas Gilg, Proffessor Institut für Rechtsmedizin München
Hummel, Christiane
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP