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临床试验/NCT00536419
NCT00536419Unknown4 期

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

Federal University of Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
53
试验地点
1
主要终点
Driving Performance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

排除标准

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

研究组 & 干预措施

2

Placebo Comparator

4 days of placebo

干预措施: Placebo (Other)

1

Experimental

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)

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Driving Performance

时间窗: After 4 days of medication

ADHD symptoms (ASRS)

时间窗: After 4 days of medication

次要结局

  • Clinical Global Impression (CGI)(After 4 days of medication)
  • Adverse effects(After 4 days of medication)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other

研究点 (1)

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