Early Phase 1
N=4
The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
Ketamine · Lactation
Bottom Line
View on ClinicalTrials.gov: NCT04285684 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine — 51.2; 22.6; 10.6; 4.5 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- ketamine in lactation (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- The Ketamine Research Foundation
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine |
51.2; 22.6; 10.6; 4.5 | — |
| PRIMARY Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine |
125.0; 48.2; 21.6; 18.5 | — |
| PRIMARY Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine |
42.6; 28.6; 18.8; 8.7 | — |
| PRIMARY Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine |
92.7; 62.4; 37.3; 32.3 | — |
| PRIMARY Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine |
.56; .55; .45; .21 | — |
| PRIMARY Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine |
2.0; 1.9; 1.4; 1.1 | — |
| PRIMARY Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine |
29.9; 28.3; 25.6; 17.5 | — |
| PRIMARY Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine |
64.1; 66.9; 54.6; 41.6 | — |
| PRIMARY Ketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine |
4.9; 6.4 | — |
| PRIMARY Norketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine |
10.3; 9.9 | — |
| PRIMARY Dehydronorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine |
.3; .3 | — |
| PRIMARY Hydroxynorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine |
30.5; 13.9 | — |
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.
Eligibility 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 90kg.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04285684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.