Phase 2 N=10 Treatment

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

Neonatal Abstinence Syndrome · Neonatal Opiate Withdrawal Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03608696 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Feb 2022

Primary outcome: Primary: Buprenorphine Pharmacokinetics

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Buprenorphine (Drug)
Age: Pediatric
Sex: All
Sponsor: Thomas Jefferson University
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.

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

View full record on ClinicalTrials.gov →

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.