drugset / Trial / NCT01723722
Treatment of Neonatal Abstinence Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.
Timeline
- Start
- 2007-01
- Primary completion
- 2009-09
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.1 mg/kg | Oral |
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.15 mg/kg | Oral |
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.2 mg/kg | Oral |
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.4 mg/kg | Oral |
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.6 mg/kg | Oral |
| Comparator | Diluted Deodorized Tincture of Opium | Unknown | 0.8 mg/kg | Oral |
| Comparator | Methadone | Other / unclassified | 0.05 mg/kg | Oral |
| Comparator | Methadone | Other / unclassified | 0.1 mg/kg | Oral |
| Comparator | Methadone | Other / unclassified | 0.15 mg/kg | Oral |