# Identification of Epigenetic Biomarkers Associated with Prenatal Exposure to Substances of Abuse

> **NIH NIH R43** · U.S. DRUG TESTING LABORATORIES, INC. · 2021 · $250,900

## Abstract

PROJECT SUMMARY
Prenatal substance use remains a significant public health concern, with defined consequences
established in the neonatal period and additional health consequences identified at birth and
through adolescence. Tobacco and alcohol remain the most frequently used substances during
pregnancy, followed by marijuana, methamphetamine, opiates and cocaine. Estimates from the
National Survey on Drug Use and Health suggest that over five percent of pregnant women use
one or more illicit substances. Prenatal exposure to substances of abuse can not only cause
neonatal abstinence syndrome (NAS) and other complications at birth, but can also lead to a
number of neurobehavioral and cognitive developmental disabilities in adolescence. Epigenetic
mechanisms, including DNA methylation, provide a mechanistic link between prenatal exposure
and health consequences following the prenatal period. Alterations to the epigenome during
prenatal development, due to environmental exposure to toxins or drugs, can induce lasting
epigenetic changes that can induce physiological changes to the fetus. While multiple studies
have already established unique methylation signatures related to prenatal exposure to tobacco
and alcohol, there are no reported human epigenetic studies on the impact of prenatal exposure
to illicit drugs on the fetal epigenome and how these perturbations impact subsequent
developmental consequences. Research to understand the epigenetic predisposition resulting
from drug exposures and identification of biomarkers specific to each substance is necessary to
identify affected neonates and tailor effective treatment interventions. This Phase I proposal will
be the first study to evaluate whole epigenome methylation signatures from newborns with
known exposure to substances of abuse in utero, identify specific methylation sites that are
significantly differentiated from non-exposed controls, and examine the correlation with birth
outcomes in newborns including severity of NAS. The differential patterns of DNA methylation
identified will be examined in a Phase II study to examine the correlation between fetal
exposure to illicit drugs, methylation patterns in exposed newborns versus healthy controls,
NAS severity, and developmental outcomes as the infants mature. Our long-term goal is to
examine a correlation between identified epigenetic changes and an increased risk of the
developmental disabilities associated with prenatal exposure to illicit drugs. Establishment of an
epigenetic biomarker of fetal exposure to illicit drugs using neonatal blood spots would be more
beneficial than current screening methods in its ability to predict fetal damage at a very early
time point allowing for prompt diagnosis and early intervention.

## Key facts

- **NIH application ID:** 10325100
- **Project number:** 1R43DA054030-01A1
- **Recipient organization:** U.S. DRUG TESTING LABORATORIES, INC.
- **Principal Investigator:** Aileen Estelle Baldwin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $250,900
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325100

## Citation

> US National Institutes of Health, RePORTER application 10325100, Identification of Epigenetic Biomarkers Associated with Prenatal Exposure to Substances of Abuse (1R43DA054030-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10325100. Licensed CC0.

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