The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

• Status: Completed
• Trial end date: 2021-01-05
• Target enrollment: 0
• Participant gender: Female

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 5 days apart.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Ketamine Research Foundation
• Treatments: Ketamine

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