Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Attention Deficit Hyperactivity Disorder (ADHD)
Intervention: Daytrana (methylphenidate transdermal system) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical University of South Carolina Official(s) and/or principal investigator(s): Aimee L. McRae-Clark, Pharm.D., Principal Investigator, Affiliation: Medical University of South Carolina
Summary
The purpose of this study is to evaluate the effectiveness and safety of DaytranaŽ in the
treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused
stimulants in the past. DaytranaŽ 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.
Clinical Details
Official title: The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Primary efficacy endpoint will be ADHD symptom severity, as measured by the Wender-Reimherr Adult Attention Deficit Disorder Scale.
Secondary outcome: Secondary efficacy endpoints will be substance use during the study and compliance with study medication.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy men and women, 18 to 65 years of age
2. 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.
3. 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)
4. ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr
Adult Attention Deficit Disorder Scale
5. All subjects will agree to and sign a written, IRB-approved informed consent
6. Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study
visit compliance
Exclusion Criteria:
1. Individuals meeting DSM-IV dependence for any substance with the exception of
nicotine and caffeine
2. 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
3. Individuals meeting DSM-IV criteria for current major depressive disorder or eating
disorder, since these individuals will likely require treatment with psychotropic
medications.
4. Individuals who present significant suicidal risk
5. 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
6. Individuals currently receiving stimulants, benzodiazepines, antidepressant or
antipsychotic medications.
7. Individuals currently receiving psychotherapy focusing on reducing ADHD symptoms, as
this could confound the effects of methylphenidate treatment
8. Pregnant or nursing women, or women who refuse to use adequate birth control, as
methylphenidate has not been approved for use in pregnancy
9. Individuals without stable housing, as contacting these individuals would be
difficult
10. Individuals with major medical illnesses (e. g., HIV, renal failure, unstable angina,
chronic obstructive pulmonary disease, infectious hepatitis)
11. 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
12. Individuals with a significant family history of cardiac abnormalities, as these
individuals may be more susceptible to cardiac adverse events
13. Individuals who are obese (greater than 30% over ideal weight or BMI greater than 30)
as this may interfere with absorption of methylphenidate
14. 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
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: April 2007
Last updated: August 14, 2009
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