The Pharmacodynamics of Ketamine in the Breast Milk of Lactating Women: (KRF-LAC)
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|ClinicalTrials.gov Identifier: NCT04285684|
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ketamine, Lactation||Drug: ketamine in lactation||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|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 Pharmacodynamics of Ketamine in the Breast Milk of Lactating Women: Quantification Over 3 Half- Life Intervals of 3 Hours Each|
|Actual Study Start Date :||December 20, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
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
- 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
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
|United States, California|
|Ketamine Research Foundation|
|San Anselmo, California, United States, 94960|