Phase 2
Completed N=10
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal Abstinence Syndrome · Neonatal Opiate Withdrawal Syndrome
Source: ClinicalTrials.gov NCT03608696 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Feb 2022
Primary outcomePrimary: Buprenorphine Pharmacokinetics
Summary
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Buprenorphine Pharmacokinetics |
— | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 36 weeks gestation
- Exposure to opioids in utero
- Demonstration of signs and symptoms of neonatal abstinence syndrome requiring pharmacologic treatment
Exclusion Criteria
- Major congenital malformations and/or intrauterine growth retardation, defined as birth weight 20 mg/dL (The need for phototherapy is not exclusionary)
- Inability of mother to give informed consent due to co-morbid psychiatric diagnosis
Data sourced from ClinicalTrials.gov (NCT03608696). 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. Informational only — not medical advice.