Study Summary
This trial is testing whether clonidine is an effective treatment for drug withdrawal in neonates. The hypothesis is that it will be effective.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 2 years of life
2 years of life
Bayley Scales of Infant and Toddler Development Third Edition
60 days
Duration of treatment
Week 6
Neurobehavioral Performance Summary Scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Morphine
1 of 2
Clonidine
1 of 2
Active Control
200 Total Participants · 2 Treatment Groups
Primary Treatment: Morphine · No Placebo Group · Phase 3
Morphine
Drug
ActiveComparator Group · 1 Intervention: Morphine · Intervention Types: DrugClonidine
Drug
ActiveComparator Group · 1 Intervention: Clonidine · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years of life
Who is running the clinical trial?
Henrietta BadaLead Sponsor
1 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Neonatal Abstinence Syndrome
31 Patients Enrolled for Neonatal Abstinence Syndrome
National Institute on Drug Abuse (NIDA)NIH
2,245 Previous Clinical Trials
5,619,200 Total Patients Enrolled
12 Trials studying Neonatal Abstinence Syndrome
1,291 Patients Enrolled for Neonatal Abstinence Syndrome
Eligibility Criteria
Age 12 - 7 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Bada, Henrietta S., Thitinart Sithisarn, Julia Gibson, Karen Garlitz, Rhonda Caldwell, Gilson Capilouto, Yinglei Li, Markos Leggas, and Patrick Breheny. 2015. “Morphine Versus Clonidine for Neonatal Abstinence Syndrome”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-2377.
- Bada, Henrietta S., Thitinart Sithisarn, Julia Gibson, Karen Garlitz, Rhonda Caldwell, Gilson Capilouto, Yinglei Li, Markos Leggas, and Patrick Breheny. 2015. “Morphine Versus Clonidine for Neonatal Abstinence Syndrome”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-2377.
- Henrietta Bada 2017. "Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03396588.
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Conditions
Cancer Related
Treatments