The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.

Condition	Treatment or Intervention	Phase
Opioid-Related Disorders	Drug: Methylphenidate	Phase I

Further Study Details: 

Expected Total Enrollment:  150

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

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

New York
      Research Foundation for Mental Hygiene, Inc., New York,  New York,  10032,  United States

Study chairs or principal investigators

Frances R Levin, M.D.,  Principal Investigator,  Research Foundation for Mental Hygiene, Inc.   

Study ID Numbers:  NIDA-11444-1; R01-11444-1
Record last reviewed:  July 2003
Last Updated:  February 16, 2005
Record first received:  May 21, 2003
ClinicalTrials.gov Identifier:  NCT00061087
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08