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Clinical Trials/NCT00536419
NCT00536419
Unknown
Phase 4

Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents

Federal University of Rio Grande do Sul1 site in 1 country53 target enrollmentSeptember 2007

Overview

Phase
Phase 4
Intervention
Placebo
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Federal University of Rio Grande do Sul
Enrollment
53
Locations
1
Primary Endpoint
Driving Performance
Last Updated
18 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
September 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

Exclusion Criteria

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

Arms & Interventions

2

4 days of placebo

Intervention: Placebo

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)

Intervention: Methylphenidate

Outcomes

Primary Outcomes

Driving Performance

Time Frame: After 4 days of medication

ADHD symptoms (ASRS)

Time Frame: After 4 days of medication

Secondary Outcomes

  • Clinical Global Impression (CGI)(After 4 days of medication)
  • Adverse effects(After 4 days of medication)

Study Sites (1)

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