CompletedEarly Phase 1ketamine

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

NCT ID

NCT04285684

Target Enrollment

4 participants

Start Date

2019-12-20

Est. Completion

2021-01-05

About This Study

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 5 days apart.

Conditions Studied

KetamineLactation

Interventions

•ketamine in lactation

Eligibility

Sex:FEMALE

Age:21 Years - 45 Years

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:• 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 Criteria:• 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

Study Locations (1)

Ketamine Research Foundation

San Anselmo, California, United States