Driving Ability of Drug Dependant Patients in Maintenance Therapy

NCT01150435 | Completed

• 1 other identifier: Hummel 2010-1
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

"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.

Conditions

Driving Ability

Study Arms (4)

Maintenance Medication D, S- Methadon

Maintenance Medication S- Methadon

Buprenorphine

Buprenorphine+ Naloxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

drug dependent patients in stable maintenance therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hummel, Christiane: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Institut für Rechtsmedizin

Munich, Baveria, 80336, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Drug screen Urin

Study Officials

• Thomas Gilg, Proffessor

  Institut für Rechtsmedizin München

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 25, 2010
• Study Start: February 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

DE (1)