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

April 22, 2019 updated by: Frances R Levin, New York State Psychiatric Institute

Treatment of Adult ADHD in Methadone Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (ACTUAL)

October 1, 2004

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

May 21, 2003

First Submitted That Met QC Criteria

May 21, 2003

First Posted (ESTIMATE)

May 22, 2003

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-011444-1,#4184R
  • R01DA011444 (U.S. NIH Grant/Contract)
  • 4184R (OTHER: NYSPI IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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