CUDDLE

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

About the Study

Currently Recruiting: Participants

Study Drug/Intervention:

  • Other: Amoxicillin
  • Other: Anakinra
  • Other: Azithromycin
  • Other: Buprenorphine
  • Other: Buproprion
  • Other: Ciprofloxacin
  • Other: Citalopram
  • Other: Clindamycin
  • Other: Cyclobenzaprine
  • Other: Doxycycline
  • Other: Duloxetine
  • Other: Escitalopram
  • Other: Fluvoxamine
  • Other: Furosemide
  • Other: Gabapentin
  • Other: Hydrochlorothiazide
  • Other: Hydrocodone
  • Other: Hydroxyurea
  • Other: Labetalol
  • Other: Levetiracetam
  • Other: Levofloxacin
  • Other: Metformin
  • Other: Nifedipine
  • Other: Ondansetron
  • Other: Oxycodone
  • Other: Paroxetine
  • Other: Remdesivir
  • Other: Rosuvastatin
  • Other: Sertraline
  • Other: Tocilizumab
  • Other: Topiramate
  • Other: Tranexamic acid (TXA)
  • Other: Trazodone
  • Other: Valganciclovir
  • Other: Venlafaxine
  • Other: Verapamil

Study Timeline: This study is expected to conclude in July 2025.

Visit the Study Website

ClinicalTrials.gov ID: NCT03511118

 

Study Objectives

The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant’s through breastmilk; or the effects this transfer may have on their infants.

Inclusion & Exclusion Criteria

Inclusion Criteria:

  • Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
  • Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Exclusion Criteria:

  • Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject’s participation in the study.
  • Known pregnancy during PK sampling.

Sponsor/Funding

  • The Emmes Company, LLC

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)