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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA016288-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine treatment | Experimental | Infants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine HCL | Drug | Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of treatment for neonatal abstinence syndrome | duration of the treatment |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Estelle B Gauda, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21287-3200 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6597462 | Background | Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51. doi: 10.1016/0165-1781(84)90039-8. | |
| 6107698 | Background | Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available. |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 19398463 | Derived | Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27. |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |