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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00061087
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : April 23, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
ADHD Opioid-Related Disorders Cocaine Dependence Drug: Methylphenidate Drug: Bupropion Other: Placebo Phase 2 Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Adult ADHD in Methadone Patients
Study Start Date : February 1998
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Arm Intervention/treatment
Active Comparator: METHYLPHENIDATE
Drug: Methylphenidate
Methylphenidate 80mg/day

Active Comparator: BUPROPION
Drug: Bupropion
Bupropion 400mg/day

Placebo Comparator: PLACEBO
Other: Placebo

Primary Outcome Measures :
  1. Cocaine use based on urine toxicology [ Time Frame: collected 3 times per week for 12 weeks of the trial or length of study participation ]
  2. ADHD symptom severity based on the ADHD Rating scale score [ Time Frame: measured once per week for 12 weeks or length of study participation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00061087

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United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute Identifier: NCT00061087    
Other Study ID Numbers: NIDA-011444-1,#4184R
R01DA011444 ( U.S. NIH Grant/Contract )
4184R ( Other Identifier: NYSPI IRB )
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Frances R Levin, New York State Psychiatric Institute:
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors