Trial Outcomes & Findings for The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women (NCT NCT04285684)

NCT ID: NCT04285684

Last Updated: 2021-12-13

Results Overview

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 for the quantification of each substance were: Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 4 participants
• Primary outcome timeframe: 3, 6, 9, and 12 hour collections
• Results posted on: 2021-12-13

Participant Flow

Participant milestones

Measure	Ketamine During Lactation Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

Baseline characteristics by cohort

Measure	Ketamine During Lactation n=4 Participants Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
Age, Customized Between 21 and 45 years	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Postpartum with Established Lactation for a Minimum of 3 Months	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 3 Hours	51.2 ng/mL Standard Deviation 18.8
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 6 Hours	22.6 ng/mL Standard Deviation 8.4
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 9 Hours	10.6 ng/mL Standard Deviation 5.4
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 12 Hours	4.5 ng/mL Standard Deviation 4.4

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 3 Hours	125.0 ng/mL Standard Deviation 44.1
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 6 Hours	48.2 ng/mL Standard Deviation 17.3
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 9 Hours	21.6 ng/mL Standard Deviation 13.9
Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 12 Hours	18.5 ng/mL Standard Deviation 6.7

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 3 Hours	42.6 ng/mL Standard Deviation 10.5
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 6 Hours	28.6 ng/mL Standard Deviation 5.2
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 9 Hours	18.8 ng/mL Standard Deviation 5.1
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 12 Hours	8.7 ng/mL Standard Deviation 6.4

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 3 Hours	92.7 ng/mL Standard Deviation 14.8
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 6 Hours	62.4 ng/mL Standard Deviation 12.9
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 9 Hours	37.3 ng/mL Standard Deviation 10.5
Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 12 Hours	32.3 ng/mL Standard Deviation 10.3

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 9 Hours	.45 ng/mL Standard Deviation .3
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 12 Hours	.21 ng/mL Standard Deviation .1
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 3 Hours	.56 ng/mL Standard Deviation .3
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 6 Hours	.55 ng/mL Standard Deviation .2

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 3 Hours	2.0 ng/mL Standard Deviation 1.1
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 6 Hours	1.9 ng/mL Standard Deviation 1.1
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 9 Hours	1.4 ng/mL Standard Deviation .7
Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 12 Hours	1.1 ng/mL Standard Deviation .7

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 3 Hours	29.9 ng/mL Standard Deviation 9.0
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 6 Hours	28.3 ng/mL Standard Deviation 10.2
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 9 Hours	25.6 ng/mL Standard Deviation 8.0
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine 12 Hours	17.5 ng/mL Standard Deviation 9.9

PRIMARY outcome

Timeframe: 3, 6, 9, and 12 hour collections

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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=4 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 3 Hours	64.1 ng/mL Standard Deviation 21.1
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 6 Hours	66.9 ng/mL Standard Deviation 13.1
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 9 Hours	54.6 ng/mL Standard Deviation 11.2
Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine 12 Hours	41.6 ng/mL Standard Deviation 9.8

PRIMARY outcome

Timeframe: 24 and 30 hour collections

Population: Based on the concentration of ketamine and its metabolites at 24 and 30 hours post ketamine administration in the first participant tested, breast milk was not collected for subsequent participants at these time frames.

Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=1 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Ketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 24 Hours	4.9 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.
Ketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 30 Hours	6.4 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.

PRIMARY outcome

Timeframe: 24 and 30 hour collections

Population: Based on the concentration of ketamine and its metabolites at 24 and 30 hours post ketamine administration in the first participant tested, breast milk was not collected for subsequent participants at these time frames.

Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=1 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Norketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 24 Hours	10.3 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.
Norketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 30 Hours	9.9 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.

PRIMARY outcome

Timeframe: 24 and 30 hour collections

Population: Based on the concentration of ketamine and its metabolites at 24 and 30 hours post ketamine administration in the first participant tested, breast milk was not collected for subsequent participants at these time frames.

Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=1 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Dehydronorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 24 Hours	.3 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.
Dehydronorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 30 Hours	.3 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.

PRIMARY outcome

Timeframe: 24 and 30 hour collections

Population: Based on the concentration of ketamine and its metabolites at 24 and 30 hours post ketamine administration in the first participant tested, breast milk was not collected for subsequent participants at these time frames.

Quantitative analysis of the concentration of ketamine and its metabolites in breast milk (collected by pumping breast milk into containers at 24 and 30 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 for the quantification of each substance were:

Ketamine: 0.25 ng Norketamine: 0.25 ng Dehydronorketamine: 0.1 ng Hydroxynorketamine: 0.25 ng

Outcome measures

Measure	Ketamine During Lactation n=1 Participants Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Hydroxynorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 24 Hours	30.5 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.
Hydroxynorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine 30 Hours	13.9 ng/mL Standard Deviation NA Standard Deviation is not calculable for one participant.

Adverse Events

Ketamine During Lactation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip E Wolfson, MD

Ketamine Research Foundation

Phone: 415-550-1700

Email: ketamine.research@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place