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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

19 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Professional Motorcycle Driver
  • Current diagnosis of ADHD

Exclusion Criteria:

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

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

4 days of placebo

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)

Outcomes

Primary Outcome Measures

Driving Performance
ADHD symptoms (ASRS)

Secondary Outcome Measures

Clinical Global Impression (CGI)
Adverse effects

Full Information

First Posted
September 26, 2007
Last Updated
September 26, 2007
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre, Honda do Brasil, Novartis, Secretaria Nacional Antidrogas
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1. Study Identification

Unique Protocol Identification Number
NCT00536419
Brief Title
Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents
Official Title
Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
4 days of placebo
Arm Title
1
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, daily dose, 4 days, oral administration
Primary Outcome Measure Information:
Title
Driving Performance
Time Frame
After 4 days of medication
Title
ADHD symptoms (ASRS)
Time Frame
After 4 days of medication
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI)
Time Frame
After 4 days of medication
Title
Adverse effects
Time Frame
After 4 days of medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Professional Motorcycle Driver Current diagnosis of ADHD Exclusion Criteria: Mental retardation ADHD treatment in the last month Psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa F Paim
Phone
55-51-21018094
Email
cfpaim@hcpa.ufrgs.br
First Name & Middle Initial & Last Name or Official Title & Degree
Renata R Goncalves
Phone
55-51-33928433
Email
renata-rfg@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Augusto P Rohde, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia M Szobot, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarissa F Paim
Phone
55-51-21018094
Email
cfpaim@hcpa.ufrgs.br
First Name & Middle Initial & Last Name & Degree
Luis Augusto P Rohde, MD
First Name & Middle Initial & Last Name & Degree
Claudia M Szobot, MD

12. IPD Sharing Statement

Links:
URL
http://www.ufrgs.br/prodah
Description
Programa de Transtornos de Déficit de Atenção/Hiperatividade

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

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