Enhancing ADHD Driving Performance With Stimulant Medication
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|ClinicalTrials.gov Identifier: NCT00572026|
Recruitment Status : Unknown
Verified September 2009 by University of Virginia.
Recruitment status was: Recruiting
First Posted : December 12, 2007
Last Update Posted : September 3, 2009
Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988; DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to incur associated injuries as a result of the accident(Murphy 1996).
Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to improve driving performance in adolescents with ADHD.
Hypothesis to be Tested:
- Main study: Just as stimulant medication improves simulation and on-road driving performance of ADHD teenagers, it is hypothesized that stimulant medication will improve routine driving performance.
- Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to occur, and the next morning at 09:00.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate Transdermal System||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing ADHD Driving Performance With Stimulant Medication|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||July 2009|
Drug: Methylphenidate Transdermal System
Daytrana wear time up to 15 hours
Other Name: Brand name = Daytrana
No Intervention: 2
No treatment for ADHD
- Video recording of driving mishaps [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572026
|Contact: Daniel J Cox, PhDemail@example.com|
|Contact: Margaret Davisfirstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Daneil J Cox, PhD 434-924-5314 email@example.com|
|Contact: Margaret Davis 434-924-0481 firstname.lastname@example.org|
|Principal Investigator: Daniel J Cox, PhD|
|Principal Investigator:||Daniel J Cox, PhD||University of Virginia|