The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

Ketamine

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 5 days apart.

Intervention / Treatment

4 subjects receiving 0.5mg/kg and 1.0mg/kg of ketamine at least 5 days apart with collection of breast milk by pumping at 3 hour intervals
  • ketamine in lactation (DRUG)
    2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals

Condition or Disease

  • Ketamine
  • Lactation

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 45 Years
    Enrollment: 4 (ACTUAL)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Basic Science

    Masking

    Clinical Trial Dates

    Start date: Dec 20, 2019 ACTUAL
    Primary Completion: Jan 05, 2021 ACTUAL
    Completion Date: Jan 05, 2021 ACTUAL
    Study First Posted: Feb 26, 2020 ACTUAL
    Results First Posted: Dec 13, 2021 ACTUAL
    Last Updated: Dec 10, 2021

    Sponsors / Collaborators

    Lead Sponsor: The Ketamine Research Foundation
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    San Anselmo, California, USA

    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: 0.5mg/kg and 1.0mg kg.

    Women are required to have been breast feeding for at least 3 months and be healthy and on no medications. Support is provided for the entire time at the site and for any at home pumping. During the period of ketamine's influence, subjects are reclining and with 2 Investigators. The initial subject's data will determine the length of time for pumping--most likely 12 hours as ketamine and the active principle metabolite have half-lives of less than 3 hours. Determination of concentration of ketamine in breast milk is being done at the UCSF Clinical lab with quantification of metabolites that are inactive as well. This research is of benefit by providing lactating women information on potential exposure of infants/children to ketamine. It will serve as a guide as KRF conducts research on postpartum depression and for women at large using ketamine for psychiatric indications.

    Participant Groups

    • Lactating women--4 subjects, 2 dosage format: ketamine 0;5mg/kg and 1.0mg/kg IM at least 5 days apart.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 21
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    • Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

    More Details

    NCT Number: NCT04285684
    Acronym: KRF-LAC
    Other IDs: KetamineResearch
    Study URL: https://clinicaltrials.gov/study/NCT04285684
    Last updated: Sep 29, 2023