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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00536419
• Other study ID #: GPPG-06450
• Status: Recruiting
• Phase: Phase 4
• First received: September 26, 2007
• Last updated: September 26, 2007
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2007
• Source: Federal University of Rio Grande do Sul
• Contact: Clarissa F Paim
• Phone: 55-51-21018094
• Email: cfpaim[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: Agencia Nacional de Vigilancia Sanitaria
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 29 Years

Eligibility

Inclusion Criteria:

• Professional Motorcycle Driver

• Current diagnosis of ADHD

Exclusion Criteria:

• Mental retardation

• ADHD treatment in the last month

• Psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis
• Substance-Related Disorders

Intervention

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)

Other:
• Placebo
Placebo, daily dose, 4 days, oral administration

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (5)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Honda do Brasil, Hospital de Clinicas de Porto Alegre, Novartis, Secretaria Nacional Antidrogas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Performance		After 4 days of medication
Primary	ADHD symptoms (ASRS)		After 4 days of medication
Secondary	Clinical Global Impression (CGI)		After 4 days of medication
Secondary	Adverse effects		After 4 days of medication

External Links

•   Programa de Transtornos de Déficit de Atenção/Hiperatividade