Driving Ability of Drug Dependant Patients in Maintenance Therapy

Driving Ability Clinical Trial

Official title:

Driving Ability of Drug Dependant Patients in Maintenance Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150435
• Other study ID #: Hummel 2010-1
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: June 24, 2010
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Hummel, Christiane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Driving Ability

Locations

Country	Name	City	State
Germany	Institut für Rechtsmedizin	Munich	Baveria

Sponsors (2)

Lead Sponsor	Collaborator
Hummel, Christiane	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany,