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The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women (KRF-LAC)

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ClinicalTrials.gov Identifier: NCT04285684
Recruitment Status : Completed
First Posted : February 26, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
The Ketamine Research Foundation

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.

Condition or disease Intervention/treatment Phase
Ketamine Lactation Drug: ketamine in lactation Early Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of Ketamine and Metabolites
Actual Study Start Date : December 20, 2019
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Ketamine

Arm Intervention/treatment
Ketamine, lactation
Lactating women--4 subjects, 2 dosage format: ketamine 0;5mg/kg and 1.0mg/kg IM at least 5 days apart.
Drug: ketamine in lactation
2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals
Other Name: Assessing concentration of ketamine in breast milk at intervals




Primary Outcome Measures :
  1. The Pharmacodynamics of Ketamine in the Breast Milk of Lactating Women: [ Time Frame: 12-24 hours at 3 hour intervals ]
    Assessing the concentration of ketamine in breast milk



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285684


Locations
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United States, California
Ketamine Research Foundation
San Anselmo, California, United States, 94960
Sponsors and Collaborators
The Ketamine Research Foundation
Publications:
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Responsible Party: The Ketamine Research Foundation
ClinicalTrials.gov Identifier: NCT04285684    
Other Study ID Numbers: KetamineResearch
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of data in peer reviewed journal including all data; and available from KRF by request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months to 1 year
Access Criteria: Public and researchers Health care professionals
URL: http://www.ketamineresearchfoundation.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Ketamine Research Foundation:
ketamine
lactation
postpartum depression
breastfeeding
infant exposure
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action