Enhancing ADHD Driving Performance With Stimulant Medication

Status unconfirmed · Not applicable

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00572026

Run by

University of Virginia

People needed

14

Starts

2007-07-01

Expected to finish

2009-07-01

Last updated by the study team

2009-09-03

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ADHD diagnosis
• Valid driver's license
• Not taking any medication for their ADHD
• Have access to a car of which they are the primary driver
• Have a history of approximately two driving collisions or citations
• Have a history of responsiveness to methylphenidate

You may not qualify if…

• Older than 25 years of age
• Bi-polar disease
• Psychosis
• Satisfy the DSM IV criteria of active depressive or anxiety disorders
• Have any medical condition that might impair driving or be contra-indicated for the use of methylphenidate
• Pregnant or intending to get pregnant for the duration of the study,breastfeeding or intending to breastfeed for the duration of the study
• Have skin allergies or skin condition that could be exacerbated by wearing the medication patch
• Have documented allergy, hypersensitivity, or intolerance to methylphenidate
• Have documented hypersensitivity to the Daytrana® adhesive backing
• Have (history of):
• seizures (except febrile seizure in infancy)
• liver or renal disease
• glaucoma
• chronic skin conditions or contact sensitivities
• current symptoms suggestive of cardiac disease
• cardiovascular disease, e.g.
• structural cardiac abnormalities
• cardiac Arrythmias
• cardiomyopathy
• hypertension
• reported ECG abnormality
• vocal tics, motor tics, Tourettes Disorder or family history of Tourettes
• Have a current diagnosis of
• Psychosis
• Bi-polar disease

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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