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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

Tracking Information
First Submitted Date  ICMJE February 24, 2020
First Posted Date  ICMJE February 26, 2020
Last Update Posted Date August 5, 2021
Actual Study Start Date  ICMJE December 20, 2019
Actual Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
Official Title  ICMJE The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of Ketamine and Metabolites
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Ketamine
  • Lactation
Intervention  ICMJE 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
Study Arms  ICMJE Ketamine, lactation
Lactating women--4 subjects, 2 dosage format: ketamine 0;5mg/kg and 1.0mg/kg IM at least 5 days apart.
Intervention: Drug: ketamine in lactation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
4
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 5, 2021
Actual Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04285684
Other Study ID Numbers  ICMJE KetamineResearch
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 6 months to 1 year
Access Criteria: Public and researchers Health care professionals
URL: http://www.ketamineresearchfoundation.com
Responsible Party The Ketamine Research Foundation
Study Sponsor  ICMJE The Ketamine Research Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Ketamine Research Foundation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP