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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: Completed study, sponsored by University of Colorado, Denver.
NCT02635568 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- OTHER Cannabis Use
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-06-30 |
What the finished NCT02635568 record still lists
NCT02635568 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Cannabis Use is the first listed.
NCT02635568 does not publish any study locations in the registry export this page uses.
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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