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Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
This study has been completed.
Study NCT00061087   Information provided by National Institute on Drug Abuse (NIDA)
First Received: May 21, 2003   Last Updated: October 15, 2009   History of Changes

May 21, 2003
October 15, 2009
February 1998
October 2004   (final data collection date for primary outcome measure)
  • Cocaine use [ Time Frame: 3x/week ] [ Designated as safety issue: No ]
  • ADHD symptom severity [ Time Frame: 1x/week ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 3x/week ] [ Designated as safety issue: Yes ]
  • Cocaine use
  • ADHD symptom severity
  • Adverse effects
Complete list of historical versions of study NCT00061087 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
Treatment of Adult ADHD in Methadone Patients

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

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • ADHD
  • Opioid-Related Disorders
  • Cocaine Dependence
  • Drug: Methylphenidate
  • Drug: Bupropion
  • Other: Placebo
  • Active Comparator: Methylphenidate
  • Active Comparator: Bupropion
  • Placebo Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
115
October 2004
October 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061087
Frances R. Levin, M.D, NYPSI
NIDA-011444-1, R01-011444-1, DPMCDA
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP