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CompletedNCT00061087Updated Apr 23, 2019

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

A Phase 2/3 interventional study of Methylphenidate and Bupropion in ADHD, Opioid-Related Disorders and Cocaine Dependence, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by New York State Psychiatric Institute · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • ADHD
  • Opioid-Related Disorders
  • Cocaine Dependence

Keywords

  • ADHD
  • Cocaine
  • Treatment
  • Methadone
03

In context

Cocaine-Related Disorders

415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.

This study's enrollment of 115 is above the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.

Browse Cocaine-Related Disorders studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Active comparator
    METHYLPHENIDATE

    Methylphenidate

    Drug: Methylphenidate

  • Active comparator
    BUPROPION

    Bupropion

    Drug: Bupropion

  • Placebo comparator
    PLACEBO

    Placebo

    Other: Placebo

Interventions

  • DrugMethylphenidate

    Methylphenidate 80mg/day

  • DrugBupropion

    Bupropion 400mg/day

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Cocaine use based on urine toxicology

    Time frame: collected 3 times per week for 12 weeks of the trial or length of study participation

  2. ADHD symptom severity based on the ADHD Rating scale score

    Time frame: measured once per week for 12 weeks or length of study participation

07

Study locations

1 site
  • Research Foundation for Mental Hygiene, Inc.
    New York, New York 10032, United States
08

References and documents

Publications

  • 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. PubMed 17088222 ↗
  • 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. PubMed 16102908 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00061087
Lead sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Frances R Levin (Director of Substance Use Disorder, New York State Psychiatric Institute) — Principal investigator
First posted
May 22, 2003
Start date
Feb 1998
Primary completion
Oct 2004
Completion
Oct 2004
Last update
Apr 23, 2019

Study contacts

Frances R Levin, M.D.
principal investigator · Research Foundation for Mental Hygiene, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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