CannabisNCT02635568
Duration of Marijuana Concentration in Breast Milk- A Pilot Study
An observational study of Cannabis and Pregnancy, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cannabis, Pregnancy, Breast Feeding
- What is being tested?
- Cannabis Use
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2016to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Eligible participants will be identified in two ways:
- 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.
- Volunteers: Patients of UCH prenatal OB clinics, postpartum unit, and in the UCH and CHCO NICUs .
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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:
- 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.
- 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.
- Describe modes of marijuana consumption in women presenting for delivery and correlate with THC concentrations and persistence in breast milk.
Read the 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.
- Conditions
- Cannabis, Pregnancy, Breast Feeding
- Being tested
- Cannabis Use
- Medical subject headings
- Marijuana Abuse, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis UseOther
Observational Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of marijuana concentration in breast milk after use during pregnancy
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.
Measured: Breast milk collection 2-5 times weekly for 6 weeks
Secondary outcomes (2)
Duration of marijuana concentration in breast milk after postnatal use
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.
Measured: Breast milk collection 2-5 times weekly for 6 weeks
Frequency of marijuana use among postpartum women
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.
Measured: One time weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Erica Wymore, MD, Principal investigator, Children's Hospital Colorado, University of Colorado Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635568
- Sponsor's protocol ID
- 15-1639
- Status last verified
- Jul 2019
- First submitted
- 14 Dec 2015
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Marijuana Concentration in Breast Milk- A Pilot Study
- ClinicalTrials.gov ID
- NCT02635568
- Acronym / sponsor ID
- 15-1639
- Conditions
- Cannabis, Pregnancy, Breast Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Describe modes of marijuana consumption in women presenting for delivery and correlate with THC concentrations and persistence in breast milk.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Eligible participants will be identified in two ways:
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis UseObservational Study | Other | – |
Primary outcome
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.
2 secondary outcomes
Duration of marijuana concentration in breast milk after postnatal use
Time frame: Breast milk collection 2-5 times weekly for 6 weeks
Frequency of marijuana use among postpartum women
Time frame: One time weekly for 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Wymore, MD principal investigator
Children's Hospital Colorado, University of Colorado Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis and Pregnancy, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of marijuana concentration in breast milk after use during pregnancy (time frame: Breast milk collection 2-5 times weekly for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.