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| Sponsors and Collaborators: |
Federal University of Rio Grande do Sul Hospital de Clinicas de Porto Alegre Honda do Brasil Novartis Secretaria Nacional Antidrogas |
|---|---|
| Information provided by: | Federal University of Rio Grande do Sul |
| ClinicalTrials.gov Identifier: | NCT00536419 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Methylphenidate Other: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents |
| Estimated Enrollment: | 53 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
2: Placebo Comparator
4 days of placebo
|
Other: Placebo
Placebo, daily dose, 4 days, oral administration
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1: Experimental
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)
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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)
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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.
Eligibility| Ages Eligible for Study: | 19 Years to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Clarissa F Paim | 55-51-21018094 | cfpaim@hcpa.ufrgs.br |
| Contact: Renata R Goncalves | 55-51-33928433 | renata-rfg@uol.com.br |
| Brazil, RS | |
| 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 | |
| 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 |
More Information
| Study ID Numbers: | GPPG-06450 |
| Study First Received: | September 26, 2007 |
| Last Updated: | September 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00536419 History of Changes |
| Health Authority: | Brazil: Agencia Nacional de Vigilancia Sanitaria |
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Dopamine Uptake Inhibitors Neurotransmitter Agents Disorders of Environmental Origin Attention Deficit and Disruptive Behavior Disorders Methylphenidate Central Nervous System Stimulants Dyskinesias Signs and Symptoms |
Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Substance-Related Disorders Hyperkinesis Neurologic Manifestations Dopamine Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Methylphenidate Disorders of Environmental Origin Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Dyskinesias |
Pharmacologic Actions Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Substance-Related Disorders Hyperkinesis Neurologic Manifestations Dopamine Agents Central Nervous System Agents |
