Phase 3
N=63
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01452789 ↗Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Mar 2020
Primary outcome: Primary: Length of Treatment — 15; 28 days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sublingual buprenorphine (Drug); oral morphine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Treatment |
15; 28 | <0.05 sig |
| SECONDARY Length of Hospitalization |
21; 33 | <0.05 sig |
| SECONDARY Number of Patients Requiring Supplemental Phenobarbital Treatment. |
5; 7 | <0.05 sig |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
7; 8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01452789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.