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Duration of Marijuana Concentration in Breast Milk- A Pilot Study

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ClinicalTrials.gov Identifier: NCT02635568
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Legalization of marijuana in Colorado for both medicinal and recreational purposes has led to a perception of its safety, which has not been well studied in pregnant or lactating women. The psychoactive component of marijuana, delta-9-tetrahydrocannabinol (THC) is lipophilic and therefore presumed to be secreted into breast milk. Additionally, the difference between modes of consumption (ie. smoked vs. edible) has not been well described in regards to THC concentration in breast milk. The purpose of this small pilot study is to describe the presence and duration of THC expression in breast milk among women who have evidence of THC exposure at the time of labor and delivery or within 72 hours of delivery. The researchers hypothesize that women with positive urine drug screen for THC within 72 hours of delivery may excrete THC in breast milk for a predicted period of time, and therefore the aim of this project is to determine timing to safely return to breastfeeding to decrease infant exposure to THC.

The specific aims are to determine in women who test positive for THC at delivery:

  1. Determine length of time THC and metabolites are detected in breast milk of mothers who have a positive urine drug screen at the time of presentation for labor and delivery or within 72 hours of delivery.
  2. Determine length of time THC and metabolites are detected in breast milk of mothers with postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on when to safely return to breastfeeding.
  3. Describe modes of marijuana consumption in women presenting for delivery and correlate with THC concentrations and persistence in breast milk.

Condition or disease Intervention/treatment
Cannabis Pregnancy Breast Feeding Other: Cannabis Use

Detailed Description:

This prospective, observational pilot study will identify women within 72 hours of delivery who have a positive urine drug screen for THC and who intend to breastfeed. Eligibility will not be dependent upon the disposition of the infant, either discharged shortly after birth or infants with NICU admission. The study will last six weeks from the time of enrollment. Mothers who consent to participate will complete an in-person survey on marijuana use and exposure during pregnancy at study entry and weekly surveys of current marijuana use. Samples of maternal breast milk, maternal urine, and infant urine will be collected at least three times, but no more than five times during the week (Monday - Friday) during infant hospitalization, dependent on maternal availability. If the infant is discharged from the hospital, visits will occur twice weekly during out-patient clinic visits. The presence of marijuana will be measured by THC concentrations in maternal breast milk, maternal urine and maternal plasma, collected by research staff at each visit. the investigators will ask mothers to refrain from feeding their baby their breast milk for at least 2 weeks after last marijuana exposure, which currently is the minimum time period recommended by lactation consultants in UCH and CHCO Neonatal Intensive Care Units (NICU). If a NICU admitted infant is medically stable to tolerate enteral feedings, they are given feedings either by mouth or by nasogastric feeding tubes, of either expressed breast milk, donor breast milk, or formula. The researchers current practice for infants admitted to the NICU is to offer donor breast to infants whose mothers cannot provide their own breast milk, for numerous reasons. Mothers of infants who are not in the NICU would be encouraged to pump breast milk and dump, for 2 weeks after last THC exposure while using formula until returning to breastfeeding. As this issue is commonly encountered in our clinical practice, the investigators find that many mothers are committed to providing safe feedings to their infants after given education regarding concerns of THC impact on infant development. The time point to safely return to breast milk following THC exposure is unknown, and is a primary aim of this study.

There are numerous documented benefits to breast milk, especially in preterm infants however sufficient literature exists to question the safety of THC's effects on the developing brain which may also be particularly susceptible in prematurity. Due to these unknown and understudied but highly concerning effects, The researchers faculty Neonatology practice has agreed to the consensus of refraining from knowingly administering breast milk from mothers actively using THC. Exemptions do occur in certain clinical settings. If this occurs during a mother's study enrollment, subsequent samples would be marked appropriately and the analytical data will be carefully examined.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duration of Marijuana Concentration in Breast Milk- A Pilot Study
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana


Intervention Details:
  • Other: Cannabis Use
    Observational Study


Primary Outcome Measures :
  1. Duration of marijuana concentration in breast milk after use during pregnancy [ Time Frame: Breast milk collection 2-5 times weekly for 6 weeks ]
    Determine length of time THC and metabolites are detected in breast milk of mothers who have a positive urine drug screen at the time of presentation for labor and delivery or within 72 hours of delivery.


Secondary Outcome Measures :
  1. Duration of marijuana concentration in breast milk after postnatal use [ Time Frame: Breast milk collection 2-5 times weekly for 6 weeks ]
    Determine length of time THC and metabolites are detected in breast milk of mothers with postnatal exposure of either ingested or inhaled marijuana, to inform recommendations on when to safely return to breastfeeding.

  2. Frequency of marijuana use among postpartum women [ Time Frame: One time weekly for 6 weeks ]
    Using a weekly survey, investigators will collect patient-reported information about modes of marijuana use and frequency. This data will be correlated with THC concentrations and persistence in breast milk.


Biospecimen Retention:   Samples Without DNA
Maternal breast milk, maternal urine, maternal plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients who test positive for THC on a urine toxicology screening who intend to breastfeed will be recruited within 72 hours of delivery.
  2. Using direct-to-patient advertising, the investigators plan to advertise the study in the UCH prenatal clinics, postpartum unit, and in the UCH and CHCO NICUs with an IRB approved flyer. Patients who volunteer will submit a confidential urine sample to the research staff when they present for delivery at UCH, or within 72 hours after delivery.
Criteria

Inclusion Criteria:

  • Eligible participants will be identified in two ways:

    1. Standard of care urine toxicology screening at the time of delivery: Women who test positive for THC on a urine toxicology screening who intend to breastfeed will be recruited within 72 hours of delivery at University of Colorado Hospital (UCH) and mothers whose infants are admitted to Children's Hospital Colorado (CHCO) NICU.
    2. Volunteers: Patients of UCH prenatal OB clinics, postpartum unit, and in the UCH and CHCO NICUs .

Exclusion Criteria:

  • Mothers who do not intend to breastfeed; mothers less than 18 years of age; mothers who have positive urine drug for other illicit drugs (cocaine, methamphetamines).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635568


Contacts
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Contact: Erica Wymore, MD (303) 520-4770 erica.wymore@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Halley J Isberg, BA    720-777-9514    Halley.Isberg@childrenscolorado.org   
Principal Investigator: Erica Wymore, MD         
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Halley J Isberg, BA    720-777-9514    Halley.Isberg@childrenscolorado.org   
Principal Investigator: Erica Wymore, MD         
Sponsors and Collaborators
University of Colorado, Denver
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Erica Wymore, MD Children's Hospital Colorado, University of Colorado Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02635568     History of Changes
Other Study ID Numbers: 15-1639
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided