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

NCT ID: NCT00536419

Last Updated: 2007-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

4 days of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo, daily dose, 4 days, oral administration

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)

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Placebo

Placebo, daily dose, 4 days, oral administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Professional Motorcycle Driver
* Current diagnosis of ADHD

Exclusion Criteria

* Mental retardation
* ADHD treatment in the last month
* Psychosis
Minimum Eligible Age

19 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Honda do Brasil

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Secretaria Nacional Antidrogas

UNKNOWN

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Principal Investigators

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Luis Augusto P Rohde, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Claudia M Szobot, MD

Role: STUDY_DIRECTOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Clarissa F Paim

Role: CONTACT

Phone: 55-51-21018094

Email: [email protected]

Renata R Goncalves

Role: CONTACT

Phone: 55-51-33928433

Email: [email protected]

Facility Contacts

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Clarissa F Paim

Role: primary

Related Links

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http://www.ufrgs.br/prodah

Programa de Transtornos de Déficit de Atenção/Hiperatividade

Other Identifiers

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GPPG-06450

Identifier Type: -

Identifier Source: org_study_id