Skip to content

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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00536419
Enrollment
53
Registered
2007-09-27
Start date
2007-09-30
Completion date
2008-09-30
Last updated
2007-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

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.

Interventions

DRUGMethylphenidate

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)

OTHERPlacebo

Placebo, daily dose, 4 days, oral administration

Sponsors

Hospital de Clinicas de Porto Alegre
CollaboratorOTHER
Honda do Brasil
CollaboratorUNKNOWN
Novartis
CollaboratorINDUSTRY
Secretaria Nacional Antidrogas
CollaboratorUNKNOWN
Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* Professional Motorcycle Driver * Current diagnosis of ADHD

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Driving PerformanceAfter 4 days of medication
ADHD symptoms (ASRS)After 4 days of medication

Secondary

MeasureTime frame
Clinical Global Impression (CGI)After 4 days of medication
Adverse effectsAfter 4 days of medication

Countries

Brazil

Contacts

Primary ContactClarissa F Paim
cfpaim@hcpa.ufrgs.br55-51-21018094
Backup ContactRenata R Goncalves
renata-rfg@uol.com.br55-51-33928433

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026