Cimetidine Excretion During Lactation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how the drug cimetidine is processed and excreted in breast milk. Researchers seek to understand the activity of certain proteins in the mammary glands of healthy breastfeeding women. The study is recruiting healthy postpartum women who are not currently taking cimetidine or other medications that might interact with it. Participants will provide important insights into the safety and effects of drugs during lactation. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its benefits for more patients, offering participants a chance to contribute to safer medication use during breastfeeding.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants taking medications that interact with cimetidine or affect specific drug transporters. It's best to discuss your current medications with the trial team to see if any need to be stopped.
What is the safety track record for this treatment?
Research has shown that cimetidine is generally safe for breastfeeding mothers and their babies. Studies have found that only a small amount of cimetidine passes into breast milk, and no side effects have been reported in breastfed babies, particularly those older than two months.
A breastfeeding baby would receive about 6.7% of the cimetidine dose taken by the mother. This small amount is not expected to cause harm. Among over-the-counter heartburn medications, cimetidine is considered safe for breastfeeding mothers.
Overall, cimetidine is well-tolerated, and no negative effects have been reported in nursing infants.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about studying cimetidine excretion during lactation because it aims to provide crucial insights into how this medication transfers into breast milk. Unlike other treatments that focus on the direct therapeutic effects of drugs, this study focuses on understanding drug safety and exposure for breastfeeding infants. By exploring how much cimetidine is excreted into breast milk, the trial can help guide safer medication use for nursing mothers, potentially impacting prescribing practices and enhancing infant safety.
What evidence suggests that this treatment might be an effective treatment for drug excretion in breast milk?
Previous studies have shown that cimetidine effectively treats heartburn and ulcers by reducing stomach acid. Research indicates that cimetidine blocks certain signals in the stomach, lowering acid levels. Although this trial does not focus on treating a specific condition, it aims to understand how cimetidine enters breast milk and how the body processes it during breastfeeding. The study will involve healthy lactating women to help ensure the safe use of cimetidine for breastfeeding mothers. Overall, cimetidine has a proven history of effectively reducing stomach acid.
Who Is on the Research Team?
Mary Hebert, PharmD, FCCP
Principal Investigator
University of Washington
Are You a Good Fit for This Trial?
This trial is for healthy, lactating or pregnant women planning to breastfeed, aged 18-50, and their nursing infants between 3 weeks to 8 months old. Participants must not be on medications that could interact with the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of cimetidine 200 mg on each of 3 study days at different postpartum stages
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Drug Excretion in Breast Milk
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator