Enhancing ADHD Driving Performance With Stimulant Medication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00572026
First received: December 10, 2007
Last updated: September 2, 2009
Last verified: September 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Enhancing ADHD Driving Performance With Stimulant Medication

Resource links provided by NLM:


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
Experimental: 1
Daytrana
Drug: Methylphenidate Transdermal System
Daytrana wear time up to 15 hours
Other Name: Brand name = Daytrana
No Intervention: 2
No treatment for ADHD

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Daniel J. Cox, PhD, University of virginia
ClinicalTrials.gov Identifier: NCT00572026     History of Changes
Other Study ID Numbers: 12189
Study First Received: December 10, 2007
Last Updated: September 2, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014