Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
Tracking Information | |||||
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First Received Date ICMJE | October 23, 2008 | ||||
Last Updated Date | August 14, 2009 | ||||
Start Date ICMJE | April 2007 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00780208 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Secondary efficacy endpoints will be substance use during the study and compliance with study medication. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD | ||||
Official Title ICMJE | The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD | ||||
Brief Summary | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Adult Attention Deficit Hyperactivity Disorder (ADHD) | ||||
Intervention ICMJE | 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.
Other Name: Daytrana Patch, Methylphenidate Patch |
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Study Arm (s) | Daytrana
Methylphenidate patch
Intervention: Drug: Daytrana (methylphenidate transdermal system) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 20 | ||||
Completion Date | February 2009 | ||||
Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00780208 | ||||
Other Study ID Numbers ICMJE | HR#16784 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Aimee L. McRae-Clark, Pharm.D., Medical University of South Carolina | ||||
Study Sponsor ICMJE | Medical University of South Carolina | ||||
Collaborators ICMJE | Shire Development LLC | ||||
Investigators ICMJE |
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Information Provided By | Medical University of South Carolina | ||||
Verification Date | August 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |