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Enhancing ADHD Driving Performance With Stimulant Medication

This study is currently recruiting participants.
Verified by University of Virginia, August 2008

Sponsored by: University of Virginia
Information provided by: University of Virginia
ClinicalTrials.gov Identifier: NCT00572026
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate Transdermal System

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

ChemIDplus related topics:   Methylphenidate hydrochloride    Methylphenidate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:   Enhancing ADHD Driving Performance With Stimulant Medication

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Video recording of driving mishaps [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   14
Study Start Date:   July 2007
Estimated Study Completion Date:   July 2009
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Daytrana
Drug: Methylphenidate Transdermal System
Daytrana wear time up to 15 hours
2: No Intervention
No treatment for ADHD

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572026

Contacts
Contact: Daniel J Cox, PhD     434-924-5314     djc4f@virginia.edu    
Contact: Margaret Davis     434-924-0481     mtd5m@virginia.edu    

Locations
United States, Virginia
University of Virginia     Recruiting
      Charlottesville, Virginia, United States, 22908
      Contact: Daneil J Cox, PhD     434-924-5314     djc4f@virginia.edu    
      Contact: Margaret Davis     434-924-0481     mtd5m@virginia.edu    
      Principal Investigator: Daniel J Cox, PhD            

Sponsors and Collaborators
University of Virginia

Investigators
Principal Investigator:     Daniel J Cox, PhD     University of Virginia    
  More Information


Responsible Party:   University of virginia ( Daniel J. Cox, PhD )
Study ID Numbers:   12189
First Received:   December 10, 2007
Last Updated:   August 6, 2008
ClinicalTrials.gov Identifier:   NCT00572026
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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