CompletedPhase 1/2

Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure

United States10 participantsStarted 2018-08-29

Plain-language 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.

Who can participate

Age range4 Weeks

SexALL

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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 \<2000 gm
✕. 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)
✕. Inability of mother to give informed consent due to co-morbid psychiatric diagnosis

What they're measuring

Buprenorphine Pharmacokinetics

Timeframe: Duration of pharmacologic treatment for neonatal abstinence syndrome up to 70 days of age

Trial details

NCT IDNCT03608696

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-11

Results submitted2021-10-18

View on ClinicalTrials.gov More Neonatal Abstinence Syndrome trials