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Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects

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ClinicalTrials.gov Identifier: NCT04422600
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief 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.


Condition or disease
Fetal Exposure Timing Unspecified

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Fetal Exposure to Cannabinoids: Exposure, Methylation and Neurodevelopmental Effects
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Group/Cohort
Mothers who report use of THC with or without CBD
Mothers who report THC and CBD usage during the trimester month of pregnancy, at a frequency of at least three time per week. Information will be collected from mothers receiving their obstetrical care at UAMS and will include data on the exact products used and the frequency of use.
Mothers who report use of CBD only
Mothers who report CBD usage during the trimester month of pregnancy, at a frequency of at least three time per week. Information will be collected from mothers receiving their obstetrical care at UAMS and will include data on the exact products used and the frequency of use.
Control Mothers
Recruitment of pregnant women who do not use THC or CBD will be conducted using the Epic MyChart research participant recruitment tool



Primary Outcome Measures :
  1. THC and CBD metabolite levels in maternal neonatal blood [ Time Frame: Within three months prior to the estimated due date ]
    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.

  2. THC and CBD metabolite level in umbilical cord blood [ Time Frame: Immediately after birth ]
    Levels of THC and CBD metabolites will be measured umbilical cord blood following prenatal drug use. These levels will be measured via liquid chromatography-mass spectrometry.

  3. THC and CBD metabolite levels in neonatal blood [ Time Frame: 24 hours after birth ]
    Levels of THC and CBD metabolites will be measured in neonatal blood following prenatal drug use. These levels will be measured via liquid chromatography-mass spectrometry.

  4. Infant motor, cognitive, and social development at 6 months of age using the Ages and Stages Questionnaire [ Time Frame: 6 months after birth ]
    To measure infant neurodevelopment, we will use the Ages and Stages Questionnaire (ASQ). The ASQ measures 5 domains/scales of child development: communication, gross motor, fine motor, problem solving, and personal-social. Each scale ranges from 0 to 60, with lower scores being indicative of deficits or poor outcomes.

  5. Infant motor, cognitive, and social development at 12 months of age using the Ages and Stages Questionnaire [ Time Frame: 12 months after birth ]
    To measure infant neurodevelopment, we will use the Ages and Stages Questionnaire (ASQ). The ASQ measures 5 domains/scales of child development: communication, gross motor, fine motor, problem solving, and personal-social. Each scale ranges from 0 to 60, with lower scores being indicative of deficits or poor outcomes.

  6. Infant motor, cognitive, and social development at 6 months of age using the Bayley Scales of Infant Development [ Time Frame: 6 months after birth ]
    To measure infant neurodevelopment, we will use the Bayley Scales of Infant and Toddler Development. The Bayley Scales measures 5 domains of child development: adaptive behavior, cognitive, language, motor, and social-emotional. Each scale ranges from 40-160, with higher scores indicative of better outcomes.

  7. Infant motor, cognitive, and social development at 12 months of age using the Bayley Scales of Infant Development [ Time Frame: 12 months after birth ]
    To measure infant neurodevelopment, we will use the Bayley Scales of Infant and Toddler Development. The Bayley Scales measures 5 domains of child development: adaptive behavior, cognitive, language, motor, and social-emotional. Each scale ranges from 40-160, with higher scores indicative of better outcomes.

  8. DNA methylation profiles in infants at 12 months of age [ Time Frame: 12 months after birth ]
    Buccal samples from infants at 12 months of age will be used to evaluate DNA methylation profiles.


Biospecimen Retention:   Samples With DNA

Five (5) mL of blood will be collected from mothers at some point in the third trimester of pregnancy. Five (5) mL of umbilical cord blood will be collected from the baby immediately after birth, followed by a 1 mL venous blood sample collected 24 hours or later following birth during the routine blood sample collection for newborn screening.

Buccal swabs will be collected from infants at 6 and 12 months of age for DNA methylation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women and infants
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Mothers who report use of THC and /or CBD and pregnant women who do not use THC or CBD. Babies will be enrolled (consent given by mothers) following birth.
Criteria

Inclusion Criteria:

  • Pregnant women
  • Age 18 and older
  • Must plan to give birth at UAMS
  • Report regular (at least 3x per week) use of THC- and/or CBD-containing product anytime during pregnancy (for experimental groups). Women who discontinue use of marijuana and/or CBD during pregnancy will still be allowed in the study.
  • Pregnant women who do not use THC or CBD will be enrolled as controls.

Exclusion Criteria:

  • Any other illicit drug use during pregnancy
  • Plan to give birth anywhere other than UAMS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422600


Contacts
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Contact: Stefanie Kennon McGill, Ph.D. 501-686-8258 skennonmcgill@uams.edu
Contact: Laura James, M.D. 501-526-0367 jameslaurap@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Stefanie Kennon-McGill, Ph.D.    501-686-8258    skennonmcgill@uams.edu   
Principal Investigator: Stefanie Kennon-McGill, Ph.D.         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Stefanie Kennon McGill, Ph.D. University of Arkansas
Publications:

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT04422600    
Other Study ID Numbers: 239611
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Arkansas:
Fetal Exposure
Cannabinoids
Methylation
Neurodevelopmental Effects