Driving Ability of Drug Dependant Patients in Maintenance Therapy

June 24, 2010 updated by: Hummel, Christiane

"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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baveria
      • Munich, Baveria, Germany, 80336
        • Institut für Rechtsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

drug dependent patients in stable maintenance therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Buprenorphine
Maintenance Medication D, S- Methadon
Maintenance Medication S- Methadon
Buprenorphine+ Naloxone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hummel, Christiane

Collaborators

Ludwig-Maximilians - University of Munich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

June 25, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • Hummel 2010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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