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

Primary Purpose

ADHD, Opioid-Related Disorders, Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Bupropion
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Cocaine, Treatment, Methadone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

METHYLPHENIDATE

BUPROPION

PLACEBO

Arm Description

Methylphenidate

Bupropion

Placebo

Outcomes

Primary Outcome Measures

Cocaine use based on urine toxicology
ADHD symptom severity based on the ADHD Rating scale score

Secondary Outcome Measures

Full Information

First Posted
May 21, 2003
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00061087
Brief Title
Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
Official Title
Treatment of Adult ADHD in Methadone Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Opioid-Related Disorders, Cocaine Dependence
Keywords
ADHD, Cocaine, Treatment, Methadone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
METHYLPHENIDATE
Arm Type
Active Comparator
Arm Description
Methylphenidate
Arm Title
BUPROPION
Arm Type
Active Comparator
Arm Description
Bupropion
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
Methylphenidate 80mg/day
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
Bupropion 400mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cocaine use based on urine toxicology
Time Frame
collected 3 times per week for 12 weeks of the trial or length of study participation
Title
ADHD symptom severity based on the ADHD Rating scale score
Time Frame
measured once per week for 12 weeks or length of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17088222
Citation
Brooks DJ, Vosburg SK, Evans SM, Levin FR. Assessment of cognitive functioning of methadone-maintenance patients: impact of adult ADHD and current cocaine dependence. J Addict Dis. 2006;25(4):15-25. doi: 10.1300/J069v25n04_02.
Results Reference
background
PubMed Identifier
16102908
Citation
Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV. Treatment of methadone-maintained patients with adult ADHD: double-blind comparison of methylphenidate, bupropion and placebo. Drug Alcohol Depend. 2006 Feb 1;81(2):137-48. doi: 10.1016/j.drugalcdep.2005.06.012. Epub 2005 Aug 15.
Results Reference
result
Links:
URL
http://stars.columbia.edu/
Description
Substance and Research Service of the Division on Substance Abuse of the NYSPI

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

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