Recruiting

Stimulant Medication

Sponsor:

University of Virginia

Code:

NCT00572026

Conditions

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Methylphenidate Transdermal System

Study Details

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study ID

NCT00572026

Start date

Jul, 2007

Status verified date

Sep, 2009

Completion date

Jul, 2009

Anticipated

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

14 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Interventions and Outcome Measures

Arms

experimental: 1

Daytrana

no intervention: 2

No treatment for ADHD

Interventions

Methylphenidate Transdermal System

Daytrana wear time up to 15 hours

Primary outcome measure

  • Video recording of driving mishaps [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Daniel J Cox, PhD

434-924-5314djc4f@virginia.edu

Margaret Davis

434-924-0481mtd5m@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Daneil J Cox, PhD

434-924-5314djc4f@virginia.edu

Margaret Davis

434-924-0481mtd5m@virginia.edu

Principal Investigator:

Daniel J Cox, PhD

More Information

Sponsor

University of Virginia

Last update posted

Sep 3, 2009

Last verified

Sep, 2009

Keywords

  • Attention deficit
  • Hyperactivity
  • Attention deficit hyperactivity disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2009-09-03.