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

This study has been completed.

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00061087
  Purpose

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


Condition Intervention Phase
ADHD
Opioid-Related Disorders
Cocaine Dependence
Drug: Methylphenidate
Drug: Bupropion
Other: Placebo
Phase II
Phase III

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

Drug Information available for:   Methadone    Methadone hydrochloride    Methylphenidate hydrochloride    Methylphenidate    8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))-    Cocaine hydrochloride    Bupropion hydrochloride    Bupropion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Treatment of Adult ADHD in Methadone Patients

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Enrollment:   115
Study Start Date:   February 1998
Study Completion Date:   October 2004
Primary Completion Date:   October 2004 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Methylphenidate
Drug: Methylphenidate
2: Active Comparator
Bupropion
Drug: Bupropion
Bupropion 400mg/day
3: Placebo Comparator
Placebo
Other: Placebo
Placebo

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061087

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

Sponsors and Collaborators

Investigators
Principal Investigator:     Frances R Levin, M.D.     Research Foundation for Mental Hygiene, Inc.    
  More Information


Substance and Research Service of the Division on Substance Abuse of the NYSPI  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Responsible Party:   NYPSI ( Frances R. Levin, M.D )
Study ID Numbers:   NIDA-11444-1, R01-11444-1
First Received:   May 21, 2003
Last Updated:   October 24, 2008
ClinicalTrials.gov Identifier:   NCT00061087
Health Authority:   United States: Federal Government;   United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
ADHD  
Cocaine  
Treatment  
Methadone  

Study placed in the following topic categories:
Cocaine-Related Disorders
Disorders of Environmental Origin
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Opioid-Related Disorders
Naphazoline
Oxymetazoline
Methadone
Dopamine
Attention Deficit Disorder with Hyperactivity
Guaifenesin
Phenylephrine
Mental Disorders
Mental Disorders Diagnosed in Childhood
Bupropion
Substance-Related Disorders
Hyperkinesis
Phenylpropanolamine
Cocaine

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Respiratory System Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Stimulants
Narcotics
Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Dopamine Agents
Analgesics
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antitussive Agents
Central Nervous System Agents
Antidepressive Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 30, 2008




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