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

NCT00536419 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2007-09-27

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

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)

OTHER

Placebo

Placebo, daily dose, 4 days, oral administration

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Honda do Brasil

    collaborator UNKNOWN

  • Novartis

    collaborator INDUSTRY

  • Secretaria Nacional Antidrogas

    collaborator UNKNOWN

  • Federal University of Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Luis Augusto P Rohde, MD · Hospital de Clinicas de Porto Alegre

  • Claudia M Szobot, MD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Completion
2008-09-30

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536419 on ClinicalTrials.gov