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NCT04285684 · ClinicalTrials.gov registry record · Early Phase 1
The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
A Early Phase 1 study, sponsored by The Ketamine Research Foundation.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT04285684: Completed Early Phase 1 study, sponsored by The Ketamine Research Foundation.
NCT04285684 is a Early Phase 1 study that has completed, run by The Ketamine Research Foundation. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04285684, a Early Phase 1 study, has completed, sponsored by The Ketamine Research Foundation.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 3, 6, 9, and 12 hours post ketamine IM administration) was performed at the Clinical Medicine and Toxicology Laboratory at UCSF School of Medicine. Sample aliquots were frozen in our conventional freezer at the clinic where the sessions took place, labelled with a HIPAA compliant code which blinded the lab to all patient data. The limits of sensitivity f
Interventions
- DRUG ketamine in lactation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2021-01-05 |
| Phase | Early Phase 1 |
What the finished NCT04285684 record still lists
NCT04285684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which ketamine in lactation is the first listed.
NCT04285684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04285684 about?
NCT04285684 is a clinical study titled "The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women". 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.
What is the current status of trial NCT04285684?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2019-12-20. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT04285684?
The interventions under investigation include: ketamine in lactation (DRUG).
Who is sponsoring clinical trial NCT04285684?
This trial is sponsored by The Ketamine Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04285684's enrollment target sits among peer trials
4 1922nd of 2000 higher than 53 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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