Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1

This project is a three armed double-blind, placebo-controlled, randomized trial comparing
the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent
ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to
receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified
by site, and whether or not cocaine is also being used. Efficacy will be measured by
treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD
symptoms and overall functional status.

Inclusion Criteria:

- Individuals who meet DSM-IV criteria for opiate dependence and are currently
maintained on methadone

- Patients must meet DSM-IV criteria for persistent adult ADHD

- Must be on stable methadone dose for at least 3 weeks

- Individuals positive for HIV will not be excluded.

Exclusion Criteria:

- Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or
substance abuse) which requires psychiatric intervention

- Patients who are physiologically dependent on either sedatives or alcohol such that
they experience symptoms requiring medical attention during periods of abstinence or
significant reduction in amount of use

- Individuals diagnosed with other forms of adult ADHD other than persistent,
particularly substance-induced ADHD

- Those who have an unstable medical condition which might make participation hazardous,
including but not restricted to: uncontrolled hypertension, (SBP >160, DBP>100, PULSE
>110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis,
uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or
history of urinary retention or seizures, or advanced AIDS will not be included

- Patients who are taking prescription psychotropic medications other than methadone

- Patients who have exhibited suicidal or homicidal behavior within the past two years

- Patients with known sensitivity to MPH or BPR

- Patients with cognitive impairment or who cannot read or understand the self-report
assessment forms unaided or are so severely disabled they cannot comply with the
requirements of the study.

- Patients unable to give full and informed consent

- Patients with a history of an eating disorder

- Patients recently convicted of a violent crime. (last two years)

- Nursing mothers and pregnant women