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The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women (KRF-LAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285684
Recruitment Status : Completed
First Posted : February 26, 2020
Results First Posted : December 13, 2021
Last Update Posted : December 13, 2021
Sponsor:
Information provided by (Responsible Party):
The Ketamine Research Foundation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Ketamine
Lactation
Intervention Drug: ketamine in lactation
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Between 21 and 45 years Number Analyzed 4 participants
4
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
2
  50.0%
Not Hispanic or Latino
2
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  25.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  25.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
Postpartum with Established Lactation for a Minimum of 3 Months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 51.2  (18.8)
6 Hours 22.6  (8.4)
9 Hours 10.6  (5.4)
12 Hours 4.5  (4.4)
2.Primary Outcome
Title Ketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 125.0  (44.1)
6 Hours 48.2  (17.3)
9 Hours 21.6  (13.9)
12 Hours 18.5  (6.7)
3.Primary Outcome
Title Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 42.6  (10.5)
6 Hours 28.6  (5.2)
9 Hours 18.8  (5.1)
12 Hours 8.7  (6.4)
4.Primary Outcome
Title Norketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 92.7  (14.8)
6 Hours 62.4  (12.9)
9 Hours 37.3  (10.5)
12 Hours 32.3  (10.3)
5.Primary Outcome
Title Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours .56  (.3)
6 Hours .55  (.2)
9 Hours .45  (.3)
12 Hours .21  (.1)
6.Primary Outcome
Title Dehydronorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 2.0  (1.1)
6 Hours 1.9  (1.1)
9 Hours 1.4  (.7)
12 Hours 1.1  (.7)
7.Primary Outcome
Title Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of .5mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 29.9  (9.0)
6 Hours 28.3  (10.2)
9 Hours 25.6  (8.0)
12 Hours 17.5  (9.9)
8.Primary Outcome
Title Hydroxynorketamine Concentration in Breast Milk, up to 12 Hours at 3 Hour Intervals, Following an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 3, 6, 9, and 12 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: ng/mL
3 Hours 64.1  (21.1)
6 Hours 66.9  (13.1)
9 Hours 54.6  (11.2)
12 Hours 41.6  (9.8)
9.Primary Outcome
Title Ketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 24 and 30 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
24 Hours 4.9 [1]   (NA)
30 Hours 6.4 [1]   (NA)
[1]
Standard Deviation is not calculable for one participant.
10.Primary Outcome
Title Norketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 24 and 30 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
24 Hours 10.3 [1]   (NA)
30 Hours 9.9 [1]   (NA)
[1]
Standard Deviation is not calculable for one participant.
11.Primary Outcome
Title Dehydronorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 24 and 30 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
24 Hours .3 [1]   (NA)
30 Hours .3 [1]   (NA)
[1]
Standard Deviation is not calculable for one participant.
12.Primary Outcome
Title Hydroxynorketamine Concentration in Breast Milk at 24 and 30 Hours After an IM Administration of 1mg/kg Ketamine
Hide Description

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

Time Frame 24 and 30 hour collections
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description:
Participants received .5mg/kg and 1mg/kg IM ketamine, at least 5 days apart
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
24 Hours 30.5 [1]   (NA)
30 Hours 13.9 [1]   (NA)
[1]
Standard Deviation is not calculable for one participant.
Time Frame Adverse event data was collected continuously starting with the first ketamine administration, through the second ketamine administration (5-14 days following the first administration), and during a formal four week follow-up thereafter.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine During Lactation
Hide Arm/Group Description Participants received 2 ketamine administrations, 0.5mg/kg and 1.0mg/kg IM, at least 5 days apart.
All-Cause Mortality
Ketamine During Lactation
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Serious Adverse Events
Ketamine During Lactation
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine During Lactation
Affected / at Risk (%)
Total   0/4 (0.00%) 
After the collection of breast milk from the first subject, it was determined that 3 hour intervals up to 12 hours was a sufficient collection period for the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Philip E Wolfson, MD
Organization: Ketamine Research Foundation
Phone: 415-550-1700
EMail: ketamine.research@gmail.com
Layout table for additonal information
Responsible Party: The Ketamine Research Foundation
ClinicalTrials.gov Identifier: NCT04285684    
Other Study ID Numbers: KetamineResearch
First Submitted: February 24, 2020
First Posted: February 26, 2020
Results First Submitted: September 8, 2021
Results First Posted: December 13, 2021
Last Update Posted: December 13, 2021