Driving Ability of Drug Dependant Patients in Maintenance Therapy

• Sponsor: Hummel, Christiane (Other)
• Overall Status: Completed
• CT.gov ID: NCT01150435
• Collaborator: Ludwig-Maximilians - University of Munich (Other)
• Enrollment: 121
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Driving Ability

Study Design

• Study Type: Observational
• Actual Enrollment: 121 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Driving Ability of Drug Dependant Patients in Maintenance Therapy
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Maintenance Medication D, S- Methadon
Maintenance Medication S- Methadon
Buprenorphine
Buprenorphine+ Naloxone

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut für Rechtsmedizin	Munich	Baveria	Germany	80336

Sponsors and Collaborators

• Hummel, Christiane
• Ludwig-Maximilians - University of Munich

Investigators

• Study Director: Thomas Gilg, Proffessor, Institut für Rechtsmedizin München

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01150435
• Other Study ID Numbers: Hummel 2010-1
• First Posted: Jun 25, 2010
• Last Update Posted: Jun 25, 2010
• Last Verified: Jun 1, 2010

Study Results

No Results Posted as of Jun 25, 2010