The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
NCT ID: NCT04285684
Last Updated: 2021-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2019-12-20
2021-01-05
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ketamine, lactation
Lactating women--4 subjects, 2 dosage format: ketamine 0;5mg/kg and 1.0mg/kg IM at least 5 days apart.
ketamine in lactation
2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals
Interventions
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ketamine in lactation
2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* No alcohol or other substances such as marijuana for 72 hours or more.
* Weight \<50kg or \> 90kg.
* Pregnancy
21 Years
45 Years
FEMALE
Yes
Sponsors
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The Ketamine Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Philip E Wolfson, MD
Role: PRINCIPAL_INVESTIGATOR
Ketamine Research Foundation
Locations
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Ketamine Research Foundation
San Anselmo, California, United States
Countries
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References
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Chang T, Glazko AJ. Biotransformation and disposition of ketamine. Int Anesthesiol Clin. 1974 Summer;12(2):157-77. doi: 10.1097/00004311-197412020-00018. No abstract available.
Clements JA, Nimmo WS, Grant IS. Bioavailability, pharmacokinetics, and analgesic activity of ketamine in humans. J Pharm Sci. 1982 May;71(5):539-42. doi: 10.1002/jps.2600710516.
Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
Little B, Chang T, Chucot L, Dill WA, Enrile LL, Glazko AJ, Jassani M, Kretchmer H, Sweet AY. Study of ketamine as an obstetric anesthetic agent. Am J Obstet Gynecol. 1972 May 15;113(2):247-60. doi: 10.1016/0002-9378(72)90774-0. No abstract available.
Wan LB, Levitch CF, Perez AM, Brallier JW, Iosifescu DV, Chang LC, Foulkes A, Mathew SJ, Charney DS, Murrough JW. Ketamine safety and tolerability in clinical trials for treatment-resistant depression. J Clin Psychiatry. 2015 Mar;76(3):247-52. doi: 10.4088/JCP.13m08852.
Weber F, Wulf H, Gruber M, Biallas R. S-ketamine and s-norketamine plasma concentrations after nasal and i.v. administration in anesthetized children. Paediatr Anaesth. 2004 Dec;14(12):983-8. doi: 10.1111/j.1460-9592.2004.01358.x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KetamineResearch
Identifier Type: -
Identifier Source: org_study_id