Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Federal University of Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital de Clinicas de Porto Alegre
Honda do Brasil
Novartis
Secretaria Nacional Antidrogas
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00536419
First received: September 26, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Driving Performance [ Time Frame: After 4 days of medication ]
  • ADHD symptoms (ASRS) [ Time Frame: After 4 days of medication ]

Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: After 4 days of medication ]
  • Adverse effects [ Time Frame: After 4 days of medication ]

Estimated Enrollment: 53
Study Start Date: September 2007
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   19 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

Exclusion Criteria:

  • Mental retardation
  • ADHD treatment in the last month
  • Psychosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536419

Contacts
Contact: Clarissa F Paim 55-51-21018094 cfpaim@hcpa.ufrgs.br
Contact: Renata R Goncalves 55-51-33928433 renata-rfg@uol.com.br

Locations
Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Clarissa F Paim    55-51-21018094    cfpaim@hcpa.ufrgs.br   
Principal Investigator: Luis Augusto P Rohde, MD         
Sub-Investigator: Claudia M Szobot, MD         
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00536419     History of Changes
Other Study ID Numbers: GPPG-06450
Study First Received: September 26, 2007
Last Updated: September 26, 2007
Health Authority: Brazil: Agencia Nacional de Vigilancia Sanitaria

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Substance-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Chemically-Induced Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014