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Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents

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ClinicalTrials.gov Identifier: NCT00536419
Recruitment Status : Unknown
Verified September 2007 by Federal University of Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
Sponsor:
Collaborators:
Hospital de Clinicas de Porto Alegre
Honda do Brasil
Novartis
Secretaria Nacional Antidrogas
Information provided by:
Federal University of Rio Grande do Sul

Brief Summary:
The purpose of this study is to determine whether motorcycle drivers with ADHD are at a greater risk for motorcycle accidents, and whether this risk can be mitigated by treatment with methylphenidate. We will evaluate the effectiveness of Methylphenidate on driving performance, among motorcycle drivers, and investigate the correlation between improvement of ADHD symptoms (inattention and impulsivity) and driving performance.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Other: Placebo Phase 4

Detailed Description:

Traffic accidents (car and motorcycle) are the second leading cause of death in 15-34 year-old males. Within this group, the prevalence of motorcycle accidents is currently increasing at a significantly higher rate than the prevalence of car accidents, and studies in the international literature suggest that motorcycle drivers comprise a distinct driver profile to car drivers. Motorcycles are, by design, more difficult to control, and lend themselves more to performing dangerous stunts. Mistakes and lapses in judgment are likely to have more severe consequences when motorcycles are involved, especially when one considers the exposed nature of the driver. This is of special concern in Brazil, where a large population of so called "motoboys" delivers almost everything upon request, from food to work documents.

It is well known that individuals with ADHD have more traffic problems, such as: a higher risk of a car accident; more violent crashes; more traffic violations and a greater chance of losing the driver's license. On a driving simulator, subjects with ADHD usually present with more errors and crashes, in comparison to normal controls. Treatment with Methylphenidate (MPH), however, has been shown to improve driving performance on the simulator (For example, subjects significantly reduce their speed when necessary as compared to a placebo group), and this in turn is a good indicator of better real-life driving performance.

At present, there are no studies on the effect of ADHD treatment with MPH specifically on motorcycle drivers. This is relevant, since the increasing prevalence of traffic accidents can attributed to increased incidence of motorcycle accidents. If the treatment proves effective, this study will contribute to a reduction in a major social and health concern.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents
Study Start Date : September 2007
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
4 days of placebo
Other: Placebo
Placebo, daily dose, 4 days, oral administration
Experimental: 1
MPH-SODAS at day 1 (0.3/mg/kg/day); day 2 (0.7/mg/kg/day);days 3 and 4 (1.0 mg/kg/day)
Drug: Methylphenidate
Methylphenidate SODAS 0.3 mg/kg/day (day 1); 0.7 mg/kg/day (day 2); 1.0 mg/kg/day (days 3 and 4)



Primary Outcome Measures :
  1. Driving Performance [ Time Frame: After 4 days of medication ]
  2. ADHD symptoms (ASRS) [ Time Frame: After 4 days of medication ]

Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: After 4 days of medication ]
  2. Adverse effects [ Time Frame: After 4 days of medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

Exclusion Criteria:

  • Mental retardation
  • ADHD treatment in the last month
  • Psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536419


Contacts
Contact: Clarissa F Paim 55-51-21018094 cfpaim@hcpa.ufrgs.br
Contact: Renata R Goncalves 55-51-33928433 renata-rfg@uol.com.br

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Clarissa F Paim    55-51-21018094    cfpaim@hcpa.ufrgs.br   
Principal Investigator: Luis Augusto P Rohde, MD         
Sub-Investigator: Claudia M Szobot, MD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Honda do Brasil
Novartis
Secretaria Nacional Antidrogas
Investigators
Principal Investigator: Luis Augusto P Rohde, MD Hospital de Clinicas de Porto Alegre
Study Director: Claudia M Szobot, MD Hospital de Clinicas de Porto Alegre

Additional Information:
ClinicalTrials.gov Identifier: NCT00536419     History of Changes
Other Study ID Numbers: GPPG-06450
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents