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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00061087
First received: May 21, 2003
Last updated: October 24, 2012
Last verified: October 2012
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Adult ADHD in Methadone Patients

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cocaine use based on urine toxicology [ Time Frame: collected 3 times per week for 12 weeks of the trial or length of study participation ] [ Designated as safety issue: No ]
  • ADHD symptom severity based on the ADHD Rating scale score [ Time Frame: measured once per week for 12 weeks or length of study participation ] [ Designated as safety issue: No ]

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
Active Comparator: METHYLPHENIDATE
Methylphenidate
Drug: Methylphenidate
Methylphenidate 80mg/day
Active Comparator: BUPROPION
Bupropion
Drug: Bupropion
Bupropion 400mg/day
Placebo Comparator: PLACEBO
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances R Levin, M.D. Research Foundation for Mental Hygiene, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00061087     History of Changes
Other Study ID Numbers: NIDA-011444-1,#4184R, R01DA011444, 4184R
Study First Received: May 21, 2003
Last Updated: October 24, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
ADHD
Cocaine
Treatment
Methadone

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Opioid-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Methylphenidate
Bupropion
Methadone
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014