Enhancing ADHD Driving Performance With Stimulant Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Virginia

Brief 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.

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Methylphenidate Transdermal System
Daytrana wear time up to 15 hours
Other Name: Brand name = Daytrana

No Intervention: 2
No treatment for ADHD

Primary Outcome Measures :
  1. Video recording of driving mishaps [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00572026

Contact: Daniel J Cox, PhD 434-924-5314
Contact: Margaret Davis 434-924-0481

United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Daneil J Cox, PhD    434-924-5314   
Contact: Margaret Davis    434-924-0481   
Principal Investigator: Daniel J Cox, PhD         
Sponsors and Collaborators
University of Virginia
Principal Investigator: Daniel J Cox, PhD University of Virginia

Responsible Party: Daniel J. Cox, PhD, University of virginia Identifier: NCT00572026     History of Changes
Other Study ID Numbers: 12189
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: September 3, 2009
Last Verified: September 2009

Keywords provided by University of Virginia:
Attention deficit
Attention deficit hyperactivity disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents