A new federally funded project aims to replace that uncertainty with numbers. It could change how clinicians counsel patients weighing addiction treatment against feeding decisions in the first months after birth.
Researchers at the Binghamton University School of Pharmacy and Pharmaceutical Sciences have received a $3.3 million R01 grant from the National Institutes of Health. The money will be used to study how opioid use disorder medications transfer through human breast milk and what those transferred drugs do to infant health.
[cards][card]$3.3 million awarded by the National Institutes of Health.[/card][card]Five years. The length of the funded project.[/card][card]Three medications in scope: buprenorphine, methadone and naltrexone.[/card][/cards]
Why the Evidence Gap Exists
Pregnant and lactating women are rarely enrolled in clinical trials. This is largely for ethical reasons tied to unknown fetal and infant risk. The practical result is that a population with real medical need ends up with the thinnest evidence base.
Zhang, who directs the university’s Pharmacokinetics and Bioanalysis Facility, said mothers deserve better information and clearer answers from their physicians. He came to Binghamton in 2022 and has previously received research funding from the Food and Drug Administration and NIH.
Medication-assisted treatment using buprenorphine, methadone or naltrexone may be compatible with breastfeeding. What remains limited is data on how much of each drug crosses into milk and how that exposure affects the infant.
How the Study Will Work
The team will build a cell-based assay to track how medications move from blood into breast milk. A clinical group at Upstate Medical University, made up of Nevena Radonjic, Cecilia Zemanek and Anastasia Sedykh, will collect samples from lactating mothers receiving medication for opioid use disorder across several clinical sites.
Zhang will use those samples to construct physiologically based pharmacokinetic models which predict drug levels in both mother and infant across different formulations.
Assistant Professor Yanyan Li will measure biomarker levels in the mother and infant samples. Yuan Fang, a statistician at Old Dominion University, rounds out the team.
Li joined the university in 2024 and studies inflammatory disease with particular interest in the gut microbiome and its connection to the brain.
Her earlier work found that intervening early in life changed the gut microbiome more substantially than intervening later.
What Researchers Hope to Produce
The five-year project is aimed at producing predictive mapping tools. It will also support drug regulation and development and reduce treatment disparities for a group the researchers describe as both underrepresented and high risk.
What This Means for Treatment Seekers
For a woman currently in addiction treatment and planning to breastfeed nothing changes today. Clinical guidance still comes from her prescriber. Stopping medication for opioid use disorder without medical supervision carries its own serious risks. This includes elevated overdose risk after a period off the medication.
What this funding signals is that the guidance she receives in a few years should be more specific than it is now. Anyone comparing rehab centers while pregnant or postpartum can reasonably ask a program how it handles medication management during lactation.
Finding the Right Rehab
Treatment programs vary widely in how they serve pregnant and postpartum patients. Useful questions include whether the program offers medication-assisted treatment on site, whether it accepts your insurance, whether it provides care coordination with your obstetrician and whether staff have experience with perinatal substance use.
You can compare programs in the Rehab.com directory by location, level of care, specialty population served, and insurance accepted. Call
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