Mode
Text Size
Log in / Sign up
N/A Completed N=14 Treatment

Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD

Adult Attention Deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00780208 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: ADHD Symptom Severity — -17.93 units on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
ADHD Symptom Severity
-17.93 —
SECONDARY
Number of Participants With Positive Drug Screen
4 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00780208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search