Enhancing ADHD Driving Performance With Stimulant Medication

• Status: Unknown status
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Central Nervous System Stimulants; Methylphenidate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Anxiety disorder

• Substance Use Disorder/Substance Abuse Disorder

Substudy: In addition to the above requirements, in order to participate in the substudy, participants must be capable of driving the simulator without experiencing simulation sickness