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NCT02635568 · ClinicalTrials.gov registry record
Duration of Marijuana Concentration in Breast Milk- A Pilot Study
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 30
- Enrollment target
NCT02635568 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 30 participants.
The verdict
NCT02635568 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study 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.
Interventions
- OTHER Cannabis Use
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02635568
The ClinicalTrials.gov registry entry for NCT02635568 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cannabis Use is the first listed.
NCT02635568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02635568 about?
NCT02635568 is a clinical study titled "Duration of Marijuana Concentration in Breast Milk- A Pilot 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 t...
What is the current status of trial NCT02635568?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2016-11. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT02635568?
The interventions under investigation include: Cannabis Use (OTHER).
Who is sponsoring clinical trial NCT02635568?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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