Overview

Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thomas Jefferson University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Buprenorphine
Morphine
Criteria
Inclusion Criteria:

- ≥ 37 weeks gestation

- Exposure to opiates in utero

- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring
treatment

Exclusion Criteria:

- 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