Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD - Full Text View

Sponsor:	Medical University of South Carolina
Collaborator:	Shire Pharmaceutical Development
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00780208

Purpose

The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Daytrana® is a stimulant medication that has been approved by the Food and Drug Administration for the treatment of ADHD in children over the age of 6 years old.

Condition	Intervention
Adult Attention Deficit Hyperactivity Disorder (ADHD)	Drug: Daytrana (methylphenidate transdermal system)

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD

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 Medical University of South Carolina:

Primary Outcome Measures:

Primary efficacy endpoint will be ADHD symptom severity, as measured by the Wender-Reimherr Adult Attention Deficit Disorder Scale. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy endpoints will be substance use during the study and compliance with study medication. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Study Completion Date:	February 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Daytrana Methylphenidate patch	Drug: Daytrana (methylphenidate transdermal system) Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Arms

Assigned Interventions

Daytrana

Methylphenidate patch

Drug: Daytrana (methylphenidate transdermal system)

Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Detailed Description:

Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in children (Biederman et al, 1997). Although treating children and adolescents with stimulants does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little is known about the abuse of prescription stimulants in adults with ADHD. A review of the literature on the abuse potential of methylphenidate in animals and humans found that methylphenidate produced reinforcing, discriminative-stimulus, and subjective effects similar to amphetamines or cocaine (Kollins et al, 2001). Although the abuse rates of methylphenidate and other stimulant medications used for the treatment of ADHD have not been empirically established, significant concern exists so that regulatory mandates are enforced to control distribution, and some physicians may be reluctant to use stimulants in patients with drug abuse histories. The introduction of a methylphenidate patch is an important advancement, as the patch formulation should increase compliance while minimizing abuse potential, making it an attractive treatment option in the large population of individuals who have a history of previous drug misuse. The primary aim of this study is to assess the efficacy of the methylphenidate patch in adult individuals with ADHD who have abused stimulants in the past. It is hypothesized that the methylphenidate patch will be efficacious in reducing ADHD symptoms in this population.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy men and women, 18 to 65 years of age
Meet DSM-IV criteria for past stimulant (cocaine, methamphetamine, or prescription stimulant) abuse or dependence, with past abuse/dependence defined as a minimum of three months since meeting DSM-IV criteria, or have exhibited a pattern of stimulant misuse. For the purposes of this study, stimulant misuse will be defined as using someone else's stimulant ADHD medication for a minimum of four times in a one-month period, and this misuse must have occurred for at least three months.
Meet DSM-IV criteria for current ADHD, determined by a clinical interview and confirmed by semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAAR-D; Conners et al, 1999)
ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr Adult Attention Deficit Disorder Scale
All subjects will agree to and sign a written, IRB-approved informed consent
Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study visit compliance

Exclusion Criteria:

Individuals meeting DSM-IV dependence for any substance with the exception of nicotine and caffeine
Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care
Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications.
Individuals who present significant suicidal risk
Individuals with significant cognitive impairment as measured by a score of less than 26 on the Mini-Mental Status Exam, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments
Individuals currently receiving stimulants, benzodiazepines, antidepressant or antipsychotic medications.
Individuals currently receiving psychotherapy focusing on reducing ADHD symptoms, as this could confound the effects of methylphenidate treatment
Pregnant or nursing women, or women who refuse to use adequate birth control, as methylphenidate has not been approved for use in pregnancy
Individuals without stable housing, as contacting these individuals would be difficult
Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
Patients with uncontrolled hypertension (defined as having blood pressure greater than 140/90 measured on 3 or more occasions), as methylphenidate treatment can be associated with increases in blood pressure
Individuals with a significant family history of cardiac abnormalities, as these individuals may be more susceptible to cardiac adverse events
Individuals who are obese (greater than 30% over ideal weight or BMI greater than 30) as this may interfere with absorption of methylphenidate
Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780208

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Aimee L. McRae-Clark, Pharm.D.

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Aimee L. McRae-Clark, Pharm.D. )
Study ID Numbers:	HR#16784
Study First Received:	October 23, 2008
Last Updated:	August 14, 2009
ClinicalTrials.gov Identifier:	NCT00780208 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Attention Deficit Hyperactivity ADHD

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 February 08, 2010