Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

• Status: Completed
• Trial end date: 2019-07-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

1. ≥ 36 weeks gestation

2. Exposure to opioids in utero

3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring pharmacologic treatment

Exclusion Criteria:

1. Major congenital malformations and/or intrauterine growth retardation, defined as birth weight <2000 gm

2. Medical illness requiring intensification of medical therapy. This includes but is not limited to suspected sepsis requiring antibiotic therapy.

3. Hypoglycemia requiring treatment with intravenous dextrose

4. Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)

5. Inability of mother to give informed consent due to co-morbid psychiatric diagnosis