Attention Deficit Hyperactivity DisorderPhase 4NCT00536419
Impact of Attention Deficit/Hyperactivity Disorder and Substance Use Disorder on Motorcycle Traffic Accidents
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 29 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Professional Motorcycle Driver
- Current diagnosis of ADHD
Who cannot join
- Mental retardation
- ADHD treatment in the last month
- Psychosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Clarissa F Paim, 55-51-21018094, cfpaim@hcpa.ufrgs.br
Luis Augusto P Rohde, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
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)
PlaceboOther
Placebo, daily dose, 4 days, oral administration
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 4 days of placebo Receives: Other: Placebo |
| 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) Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Performance
Measured: After 4 days of medication
ADHD symptoms (ASRS)
Measured: After 4 days of medication
Secondary outcomes (2)
Clinical Global Impression (CGI)
Measured: After 4 days of medication
Adverse effects
Measured: After 4 days of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startSep 2007
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Honda do Brasil, Novartis, Secretaria Nacional Antidrogas
- Investigators
- Luis Augusto P Rohde, MD, Principal investigator, Hospital de Clinicas de Porto AlegreClaudia M Szobot, MD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536419
- Sponsor's protocol ID
- GPPG-06450
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 27 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Motorcycle Accidents, Attention Deficit/Hyperactivity Disorder and Substance Use Disorder and Motorcycle Accidents
- ClinicalTrials.gov ID
- NCT00536419
- Acronym / sponsor ID
- GPPG-06450
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre, Honda do Brasil, Novartis, Secretaria Nacional Antidrogas
- Study start
- Sep 2007
- Study completion
- Sep 2008 (estimated)
- First posted
- 27 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Other: Placebo4 days of placebo |
| 1 | Experimental | Drug: MethylphenidateMPH-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) |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Professional Motorcycle Driver
- Current diagnosis of ADHD
Key exclusion criteria (3 listed)
- Mental retardation
- ADHD treatment in the last month
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateMethylphenidate SODAS 0.3 mg/kg/day (day 1); 0.7 mg/kg/day (day 2); 1.0 mg/kg/day (days 3 and 4) | Drug | 1 |
| PlaceboPlacebo, daily dose, 4 days, oral administration | Other | 2 |
Primary outcome
Driving Performance
Time frame: After 4 days of medication
ADHD symptoms (ASRS)
Time frame: After 4 days of medication
2 secondary outcomes
Clinical Global Impression (CGI)
Time frame: After 4 days of medication
Adverse effects
Time frame: After 4 days of medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
- Programa de Transtornos de Déficit de Atenção/HiperatividadeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Augusto P Rohde, MD principal investigator
Hospital de Clinicas de Porto Alegre
Claudia M Szobot, MD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clarissa F Paim (55-51-21018094, cfpaim@hcpa.ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Performance (time frame: After 4 days of medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2007; AzTrials last refreshed its copy on 7 Nov 2026.