Status:
COMPLETED
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a \~30%...
Detailed Description
This was a single-site, randomized, double-blind, double-dummy, parallel-group clinical trial. Potential patients were identified in the pre-natal period by staff of the Thomas Jefferson University Fa...
Eligibility Criteria
Inclusion
- ≥ 37 weeks gestation
- Exposure to opiates in utero
- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
Exclusion
- Major congenital malformations and/or intrauterine growth retardation
- Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
- Hypoglycemia requiring treatment with intravenous dextrose.
- Bilirubin \>20 mg/dL (The need for phototherapy is not exclusionary)
- Concomitant benzodiazepine or severe alcohol abuse , self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth,
- Concomitant use of Cytrochrom (CYP) 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
- Seizure activity or other neurologic abnormality
- Breast feeding
- Inability of mother to give informed consent due to co-morbid psychiatric diagnosis
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01452789
Start Date
November 1 2011
End Date
June 1 2016
Last Update
March 24 2020
Active Locations (1)
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1
Thomas Jefferson University Hosptial
Philadelphia, Pennsylvania, United States, 19107