Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD

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.

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