Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Driving Performance [After 4 days of medication]
- ADHD symptoms (ASRS) [After 4 days of medication]
Secondary Outcome Measures
- Clinical Global Impression (CGI) [After 4 days of medication]
- Adverse effects [After 4 days of medication]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Professional Motorcycle Driver
-
Current diagnosis of ADHD
Exclusion Criteria:
-
Mental retardation
-
ADHD treatment in the last month
-
Psychosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS | Brazil | 90035-003 |
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GPPG-06450