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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA011444 | U.S. NIH Grant/Contract | View source | |
| 4184R | Other Identifier | NYSPI IRB |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| METHYLPHENIDATE | Active Comparator | Methylphenidate |
|
| BUPROPION | Active Comparator | Bupropion |
|
| PLACEBO | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Methylphenidate 80mg/day |
| |
| Bupropion |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine use based on urine toxicology | 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 | measured once per week for 12 weeks or length of study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances R Levin, M.D. | Research Foundation for Mental Hygiene, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Foundation for Mental Hygiene, Inc. | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17088222 | Background | 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. | |
| 16102908 | Result | 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. |
| Label | URL |
|---|---|
| Substance and Research Service of the Division on Substance Abuse of the NYSPI | View source |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D009293 | Opioid-Related Disorders |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Bupropion 400mg/day |
|
| Placebo | Other | Placebo |
|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |