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NCT04422600 · ClinicalTrials.gov registry record
Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects
A clinical trial, sponsored by University of Arkansas.
- Completed
- Registry status
- 72
- Enrollment target
NCT04422600: Completed study, sponsored by University of Arkansas.
NCT04422600 is a clinical trial that has completed, run by University of Arkansas. The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04422600 has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- 72 participants
- Enrollment target
Study Summary
Cannabis is a very popular drug for both recreational and medicinal use. An estimated 20% of adults in the United States report using cannabis in the past month, and this number continues to increase each year. As of 2018, medical use of cannabis is legal in 33 states and the District of Columbia. Recreational use is legal in 10 states, and it is decriminalized in 15 states. Hemp-derived cannabidiol (CBD) is legal in all states. Due to the rapidly changing legal status across the country, the demand for cannabinoids (which are specific components of cannabis), such as THC and CBD, are also rapidly increasing. Studies have shown a significant increase in marijuana use among pregnant and parenting women following state-wide legalization, and this could have significant implications for the health and development of children born to these women. While there is a growing effort to evaluate the health effects of cannabinoids, especially during pregnancy, there is still relatively little known about the long term neurodevelopmental outcomes, such as emotional regulation, attention, and intelligence, in children born to mothers who used any sort of cannabinoid during pregnancy. The few studies that have been performed that look at longer term outcomes were epidemiological and self-reported in nature, and cannot accurately correlate neurodevelopmental outcomes with precise dosage and exposure levels during pregnancy. Importantly, the THC content of marijuana has dramatically increased in recent years, with THC concentration and purity being the highest in history. It is estimated that cannabis potency has increased 3-fold over the past 2 decades. Many of the previous studies examining prenatal cannabis use and fetal outcomes reflected lower potency cannabis, which is not relevant to today's exposure levels. Additionally, there are no published studies to-date that evaluate fetal exposure to CBD or neurodevelopmental outcomes in infants who were exposed to CBD prenatally.
Primary Outcome
Levels of THC and CBD metabolites will be measured in maternal blood following prenatal drug use. These levels will be measured via liquid chromatography-mass spectrometry.
Interventions
- OTHER There is no other intervention, only clinical treatment.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2023-08-01 |
What the finished NCT04422600 record still lists
NCT04422600 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 72 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which There is no other intervention, only clinical treatment. is the first listed.
NCT04422600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04422600 about?
NCT04422600 is a clinical study titled "Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects". Cannabis is a very popular drug for both recreational and medicinal use. An estimated 20% of adults in the United States report using cannabis in the past month, and this number continues to increase each year. As of 2018, medical use of cannabis is legal in 33 states and the District of Columbia. R...
What is the current status of trial NCT04422600?
This trial is currently completed. The enrollment target is 72 participants. The study started on 2020-02-26. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT04422600?
The interventions under investigation include: There is no other intervention, only clinical treatment. (OTHER).
Who is sponsoring clinical trial NCT04422600?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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