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

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Placebo; Drug: Methylphenidate

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 Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Clarissa F Paim; Phone Number: 55-51-21018094; Email: cfpaim@hcpa.ufrgs.br
      • Principal Investigator: Luis Augusto P Rohde, MD
      • Sub-Investigator: Claudia M Szobot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 29 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Professional Motorcycle Driver
• Current diagnosis of ADHD

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Driving Performance	After 4 days of medication
ADHD symptoms (ASRS)	After 4 days of medication

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression (CGI)	After 4 days of medication
Adverse effects	After 4 days of medication

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Collaborators: Novartis; Hospital de Clinicas de Porto Alegre; Honda do Brasil; Secretaria Nacional Antidrogas
• Investigators: Principal Investigator: Luis Augusto P Rohde, MD, Hospital de Clínicas de Porto Alegre; Study Director: Claudia M Szobot, MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

Helpful Links

• Programa de Transtornos de Déficit de Atenção/Hiperatividade

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Study Completion (ANTICIPATED): September 1, 2008

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 26, 2007
• First Posted (ESTIMATE): September 27, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2007
• Last Update Submitted That Met QC Criteria: September 26, 2007
• Last Verified: September 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Substance-Related Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: GPPG-06450