Status:
COMPLETED
The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
Lead Sponsor:
The Ketamine Research Foundation
Conditions:
Ketamine
Lactation
Eligibility:
FEMALE
21-45 years
Phase:
EARLY_PHASE1
Brief Summary
Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least ...
Detailed Description
Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least ...
Eligibility Criteria
Inclusion
- • Age 21-45
- Postpartum with established lactation for a minimum of 3 months.
- Ability to pump breast milk and to provide a reservoir for infant feeding prior to the study; or acceptance of bottle feeding by the infant.
- In good health-normal BP/P; afebrile-temp ascertained; review of systems by MD; absence of diagnosed illnesses.
- Not pregnant--Pregnancy tested for before each administration by urine assay.
Exclusion
- • Hypertension with a BP greater than 145/90
- Subjects must be off all psychiatric medications specifically; medications and supplements, or evaluated by the PI for non-interference
- No alcohol or other substances such as marijuana for 72 hours or more.
- Weight \<50kg or \> 90kg.
- Pregnancy
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04285684
Start Date
December 20 2019
End Date
January 5 2021
Last Update
December 13 2021
Active Locations (1)
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1
Ketamine Research Foundation
San Anselmo, California, United States, 94960