The Influence of in Utero Cannabis Exposure on Neonatal Brain Morphology and Structural Connectivity

NCT03718520 | Completed

• 2 other identifiers: 18-0004R21DA043833
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

Cannabis is the most commonly used drug by women during pregnancy with an estimated prevalence of use in Colorado of 5.7%. THC and its metabolites freely cross the placenta and blood-brain barrier to bind with cannabinoid receptors, disrupting the endogenous cannabinoid signaling system during a critical period of development of cortical circuitry structure and function. The density of cannabinoid receptors in the developing brain is high, especially in the limbic areas and prefrontal lobes. Research in animal models suggests synaptic plasticity in the prefrontal lobes as well the amygdala and hippocampus are impacted by the prenatal cannabis exposure; regions associated with both cognitive and emotional control, thus influencing long-term deficiencies in attention and impulsivity. This pilot study will collect preliminary data on the structural impact of in utero cannabis exposure on region-specific morphology and structural connectivity of white matter tracts that connect to the prefrontal lobes and the limbic regions shortly after birth, before confounding by the postnatal environment becomes a major influence.

Conditions

Cannabis Use Disorder; PREG1; Drug Use; Fetal Exposure During Pregnancy; Neurodevelopmental Abnormality

Keywords

cannabis; fetal programming; pregnancy; infant neuroimaging

Outcome Measures

Primary Outcomes (2)

• region specific grey matter volume (mm^2) in the PFC and limbic regions

  region specific volume (mm\^2)

  2 weeks postnatal age

• structural integrity measured by fractional anisotrophy of white matter tracks that connect the PFC and limbic regions

  mean fractional anisotrophy

  2 weeks postnatal age

Secondary Outcomes (1)

• Negative affectivity based on a subscale from the Infant Behavioral Questionnaire (Rothbart, 1981)

  1 year postpartum

Study Arms (2)

prenatal exposed to cannabis

50 mother-infant pairs with self-reported maternal chronic cannabis use during pregnancy

Other: no intervention, this is a purely observational study

prenatal not-exposed to cannabis

60 mother-infant pairs with no self-reported maternal cannabis use during pregnancy

Other: no intervention, this is a purely observational study

Interventions

no intervention, this is a purely observational study OTHER

No intervention

prenatal exposed to cannabis; prenatal not-exposed to cannabis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study plans to enroll pregnant women.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be an observational, pre-birth prospective pilot study of 110 mother-infant pairs (50 with prenatal cannabis exposure and 60 unexposed pairs) who deliver at two academic medical centers in the Denver Metro area of Colorado (Denver Health Medical Center and the University of Colorado Hospital at Anschutz. Unexposed controls will be frequency matched to exposed cases by maternal education level. To isolate the influence of cannabis exposure, mothers using tobacco, alcohol or other drugs during pregnancy will be excluded.

You may qualify if:

• pregnant women who are receiving prenatal care at the University of Colorado Hospital at Anschutz (UCH) or Denver Health Medical Center.
• maternal positive urine toxicology screen for cannabis at any clinical prenatal visit or self-report of cannabis during pregnancy at a clinical visit
• greater than ≥ 28 weeks gestation,
• aged ≥18 years,
• expecting a singleton birth,
• live in Colorado, and plan to deliver at UCH or Denver Health Medical Center .

You may not qualify if:

• use of tobacco, alcohol or other drugs during pregnancy,
• serious chronic diseases (cancer, psychiatric diseases, steroid-dependent asthma, pre-existent diabetes mellitus of any kind),
• mothers who subsequently experience a fetal death or deliver a premature infant (\< 37 weeks of gestation).
• suspicion of metal in body or other MRI contraindications in either the mother or infant.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal urine at 28-36 weeks gestation; maternal plasma and urine at delivery; neonate urine, meconium, cord blood and cord segment shortly after birth; maternal urine at 2 weeks postpartum; maternal urine at 1 year postpartum

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Tessa Crume, PhD, MSPH

  University of Colorado, Colorado School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: November 7, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)