Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
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ClinicalTrials.gov Identifier: NCT00061087
Recruitment Status :
First Posted : May 22, 2003
Last Update Posted : May 16, 2018
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute
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.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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)