|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00061087 |
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 II Phase III |
| MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Treatment of Adult ADHD in Methadone Patients |
| 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 |
|
1: Active Comparator
Methylphenidate
|
Drug: Methylphenidate |
|
2: Active Comparator
Bupropion
|
Drug: Bupropion
Bupropion 400mg/day
|
|
3: Placebo Comparator
Placebo
|
Other: Placebo
Placebo
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |||||
| Research Foundation for Mental Hygiene, Inc. | |||||
| New York, New York, United States, 10032 | |||||
| Principal Investigator: | Frances R Levin, M.D. | Research Foundation for Mental Hygiene, Inc. |
More Information
Substance and Research Service of the Division on Substance Abuse of the NYSPI 
  |
| Responsible Party: | NYPSI ( Frances R. Levin, M.D ) |
| Study ID Numbers: | NIDA-11444-1, R01-11444-1 |
| First Received: | May 21, 2003 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00061087 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
|
|
|
|