Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents
Recruitment status was Recruiting
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.
Attention Deficit Hyperactivity Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents|
- Driving Performance [ Time Frame: After 4 days of medication ]
- ADHD symptoms (ASRS) [ Time Frame: After 4 days of medication ]
- Clinical Global Impression (CGI) [ Time Frame: After 4 days of medication ]
- Adverse effects [ Time Frame: After 4 days of medication ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2008|
Placebo Comparator: 2
4 days of placebo
Placebo, daily dose, 4 days, oral administration
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)
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)
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.
|Contact: Clarissa F Paimfirstname.lastname@example.org|
|Contact: Renata R Goncalvesemail@example.com|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-003|
|Contact: Clarissa F Paim 55-51-21018094 firstname.lastname@example.org|
|Principal Investigator: Luis Augusto P Rohde, MD|
|Sub-Investigator: Claudia M Szobot, MD|
|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|