CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
There is no other intervention, only clinical treatment.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04422600
NCT04422600N/ACompleted

Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects

University of Arkansas·observational·Posted Jun 9, 2020·Updated Sep 3, 2024

In Brief

An observational study evaluating There is no other intervention, only clinical treatment. for Fetal Exposure Timing Unspecified. Completed, enrolled 72 participants across 1 site.

Detailed 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. Finally, the causes behind possible neurodevelopmental changes in children exposed to cannabis prenatally have not been thoroughly explored, particularly in humans. It is thought that epigenetic modifications, or changes to DNA, may play a role in changes to the developing fetal brain after prenatal exposure to cannabis, but few studies have evaluated this quantitatively in humans.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 9, 2020
Enrollment StartFeb 26, 2020
Primary CompletionMay 1, 2023
Study CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.1 years ago

Interventions

There is no other intervention, only clinical treatment.other

The investigators will then correlate that exposure with neurodevelopmental outcomes.