Enhancing ADHD Driving Performance With Stimulant Medication - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

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

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

No publications provided

Responsible Party:	University of virginia ( Daniel J. Cox, PhD )
Study ID Numbers:	12189
Study First Received:	December 10, 2007
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00572026 History of Changes
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:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009