The increase in opioid use disorder (OUD) among women of reproductive age demonstrates an urgent need for safe and effective treatment strategies for women who are breastfeeding. This population is rarely, if ever, studied — but researchers at the Binghamton University, State University of New York School of Pharmacy and Pharmaceutical Sciences (SOPPS) aim to change that.
“I started to think about what we can do to enhance drug safety in this population,” said Associate Professor and Director of the Pharmacokinetics and Bioanalysis Facility Tao Zhang. “In new drug development, those populations are often not included in clinical trials. So, there's a knowledge gap, for ethical reasons, about whether it is safe to take medications and how much of those medications will go to breast milk. Mothers deserve knowledge in this area and sure answers from their physicians.”
While medication-assisted treatment (MAT) with buprenorphine, methadone, or naltrexone may be compatible with breastfeeding, data on how those drugs transfer into breast milk and then how the transferred drugs affect infant health remain limited.
To study and collect this data, Zhang and Assistant Professor of Pharmaceutical Sciences Yanyan Li, together with the Upstate Medical University clinical team composed of Nevena Radonjic, Cecilia Zemanek, and Anastasia Sedykh and Assistant Professor at Old Dominion University and statistician Yuan Fang, were recently awarded a $3.3 million R01 grant from the National Institutes of Health (NIH) . Titled “Integrating A Novel Human Mammary Epithelium Assay with Mother-Infant PBPK-PD Modeling for Precision Dosing of OUD Medications in Lactating Mothers,” the study aims to study drug transfer through human breast milk.
Zhang and Li, who have been working together over the last several years to reach this goal, make good collaborators, despite their different research focuses.
“Dr. Li and I have been collaborating for a long time in other projects in the cancer and inflammation area, and so when I started to work on this proposal, it was natural that we combined our strengths. People are not only interested in how much of the drug goes to breast milk, but they are concerned — if you know a drug goes to breast milk and infants drink that milk, what will the consequence be?”
Zhang came to Binghamton in 2022 with research focused on pharmacokinetic modeling and has since then received several research grants from the U.S. Food and Drug Administration (FDA) and NIH; Li joined the University in 2024 and focuses on inflammatory diseases. She is particularly interested in gut inflammation and microbiome and brain connection, including how maternal stress and exposure to drugs and diseases could impact offspring health.
“Our previous research found that early life intervention could change the gut microbiome much more dramatically as compared to interventions later in the life stage, conferring a stronger protection against inflammatory diseases,” Li said. “This project can help us have a better understanding of how maternal drug use in general could impact offspring inflammation and possibly be mediated by the gut microbiome in a novel way.”
Clinical, evidence-based guidance on drug transfer during lactation is limited, so Zhang, Li, and other collaborators will use the five-year grant to achieve several specific aims to improve that knowledge base. The team will develop a cell-based assay to study medication movement from blood to breast milk. The clinical team at Upstate Medical University will collect clinical samples from lactating mothers on MAT from several clinical sites. These samples will be analyzed and used by Zhang to build physiologically based pharmacokinetic (PBPK) models. These models will then predict drug levels in mothers and infants across formulations. These mother and infant samples will also be used for measuring biomarker levels by Li. The team hopes to explore the possible connections between early life drug exposure and an infant's health.
Zhang and Li hope that the project and the grant itself bring further collaboration to the University.
“As a newer pharmacy school with younger faculty, we are doing very well in terms of our accreditation, rankings, and NAPLEX scores. I'm very happy that we can bring this grant to our school, which can improve the research we can demonstrate,” Zhang said.
Overall, they hope these approaches will address a critical gap in maternal care, creating data that can then drive predictive-mapping tools, support drug regulations and development, and reduce disparities in treatment for a highly vulnerable population — informing safer, personalized treatment plans for breastfeeding women with OUD.
“We hope in the next 10 years, through our team's research working on this underrepresented and very high-risk population, we will gain more knowledge and help physicians give more informed advice,” Li said. “It will help patients who are going through these therapies feel more comfortable feeding their infants.”