Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
Primary Purpose
Adult Attention Deficit Hyperactivity Disorder (ADHD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daytrana (methylphenidate patch)
Sponsored by
About this trial
This is an interventional treatment trial for Adult Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Attention Deficit Hyperactivity ADHD
Eligibility 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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Daytrana (methylphenidate patch)
Arm Description
Methylphenidate patch
Outcomes
Primary Outcome Measures
ADHD Symptom Severity
Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).
Secondary Outcome Measures
Number of Participants With Positive Drug Screen
Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens
Full Information
NCT ID
NCT00780208
First Posted
October 23, 2008
Last Updated
June 12, 2018
Sponsor
Medical University of South Carolina
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT00780208
Brief Title
Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
Official Title
The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
Attention Deficit Hyperactivity ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daytrana (methylphenidate patch)
Arm Type
Other
Arm Description
Methylphenidate patch
Intervention Type
Drug
Intervention Name(s)
Daytrana (methylphenidate patch)
Other Intervention Name(s)
Daytrana Patch, Methylphenidate Patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD Symptom Severity
Description
Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Drug Screen
Description
Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee L. McRae-Clark, Pharm.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
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