NIH-funded research R01 grant

Precision dosing for breastfeeding mothers on opioid treatment

Official title: Integrating A Novel Human Mammary Epithelium Assay with Mother-Infant PBPK-PD Modeling for Precision Dosing of OUD Medications in Lactating Mothers

Funded at State University of Ny,binghamton · NIH-11339865 · Data updated 2026-11-12

Aims to build a model-guided method to predict drug exposure for mothers with opioid use disorder and their breastfed babies to support safer dosing.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionState University of Ny,binghamton
NIH-funded
Lab location1 site (Binghamton, United States)
Project startAugust 1, 2026
Project endMay 31, 2031
Funding year2026
Award (this year)$689,676
NIH project number1R01DA065561-01
Project IDNIH-11339865 on NIH RePORTER

Who could benefit from this research

Could help

Lactating mothers receiving medication-assisted treatment for opioid use disorder and their breastfeeding infants.

Less likely to help

Pregnant or non-lactating individuals and those not on MAT are unlikely to benefit from this study.

What this research studies

This project creates a lactation-specific, human mammary barrier model and combines it with real-world data from breastfeeding mothers on MAT to predict how drugs pass into breast milk and affect infants. Researchers will gather paired blood and milk samples, develop PBPK models, and integrate infant health markers to forecast exposure for different formulations. The work blends lab models, clinical samples, and computer simulations to produce practical dosing guidance for lactating women who are treated for OUD. The goal is to give clinicians and families clearer information to minimize infant exposure while maintaining maternal treatment efficacy.

Why it matters

Potential benefit: If successful, the project could lead to safer, more precise dosing of OUD medications during breastfeeding, protecting infant health while supporting maternal recovery.

How similar studies have gone: Previous work has shown that integrating lab models with clinical data can improve exposure predictions, but this approach is novel in the context of lactation and OUD medications.

Where this research is happening

  • State University of Ny,binghamton
    Binghamton, United States
    Active

Researchers

  • Principal investigator: Zhang, Tao — State University of Ny,binghamton
  • Study coordinator: Zhang, Tao

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.