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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2004-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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ADHD Opioid-Related Disorders Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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METHYLPHENIDATE

Methylphenidate

Group Type ACTIVE_COMPARATOR

Methylphenidate

Intervention Type DRUG

Methylphenidate 80mg/day

BUPROPION

Bupropion

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Bupropion 400mg/day

PLACEBO

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Methylphenidate

Methylphenidate 80mg/day

Intervention Type DRUG

Bupropion

Bupropion 400mg/day

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No