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Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects

NCT04422600 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2024-09-03

No results posted yet for this 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.

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.

Conditions

  • Fetal Exposure Timing Unspecified

Interventions

OTHER

There is no other intervention, only clinical treatment.

The investigators will then correlate that exposure with neurodevelopmental outcomes.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Stefanie Kennon McGill, Ph.D. · University of Arkansas

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2023-05-01
Completion
2023-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422600 on ClinicalTrials.gov