- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01150435
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Baveria
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Munich, Baveria, Tyskland, 80336
- Institut für Rechtsmedizin
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Buprenorfin
|
Maintenance Medication D, S- Methadon
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Maintenance Medication S- Methadon
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Buprenorphine+ Naloxone
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Thomas Gilg, Proffessor, Institut für Rechtsmedizin München
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Hummel 2010-1
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