Expert Panel Meeting to Discuss Study Design for a Longitudinal Study of the Impact of Prenatal Opioid and other Substance Exposure on Brain and Behavioral Development

Notice Number: NOT-DA-18-047

Key Dates
Release Date: October 19, 2018

Related Announcements
None

Issued by
National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Problem Statement:  There has been a dramatic increase in the number of babies who have been prenatally exposed to opioids due to the opioid crisis. Between 2004 and 2014, the number of infants born with neonatal opioid withdrawal syndrome (NOWS; also known as neonatal abstinence syndrome [NAS]) increased 433% from 1.5 to 8.0 per 1000 hospital births which translates into one neonate born with NOWS every 15 minutes. As the opioid crisis continues to escalate, these numbers will also increase, and we do not know what the long-term implications of early exposure to opioids (or to medications used to treat opioid use disorder) will be. In addition, other drugs continue to be used during pregnancy and afterwards when many women are breastfeeding. The National Survey on Drug Use and Health indicates that in 2016, 6.3% of pregnant women used an illicit drug (Center for Behavioral Health Statistics and Quality, 2017), and many used more than one drug.

A large and growing body of evidence indicates that early exposure to substances, including pre- or perinatally, is linked to greater risk for developing substance use disorders. Prenatal exposure is also associated with other behavioral problems, including ADHD, conduct disorder, anxiety, etc. However, a causal link is difficult to establish due to confounding factors such as socioeconomic, environmental, and genetic influences. Thus, a meeting is being convened to discuss the research needs to understand and disentangle the complex and interrelated factors that may impact the long-term consequences of pre- and perinatal substance exposure.  

Key research objectives include, but are not limited to:

  • Understanding variability in individual developmental trajectories (e.g., brain, cognitive, emotional, social, academic) from birth through childhood.
  • Understanding the impact of pre- and postnatal exposure to opioids, opioid treatment medications, cannabis, alcohol, tobacco, other prescription or illicit substances (alone or in combination) on developmental trajectories.
  • Investigating the role of sex, genetic, epigenetic, social and other environmental factors on risk/resilience related to structural and functional brain development, social/behavioral/academic achievement, and future substance use and mental disorders. 

The goal of this meeting is to discuss study design and related issues (e.g., sampling strategy, recruitment and retention of high risk populations, bioethical and social service implications) for a longitudinal study of the impact of pre- and postnatal substance exposure (including opioids, opioid treatment medications, cannabis, alcohol, tobacco, other prescription or illicit substances, alone or in combination) on brain development, mental illness, substance use, and social/behavioral/academic achievement. It is envisioned that successful execution of a program of this breadth and depth will require a broad interdisciplinary team of investigators with collective expertise in pregnancy, neonatal, and early childhood affective, cognitive, and social development; longitudinal cohort studies; developmental neuroimaging; and social/legal and environmental issues.

Input and advice from the extramural community will be actively encouraged through multiple mechanisms.  The NIH will hold a workshop on October 22, 2018 at 6001 Executive Blvd Bethesda MD 20892, which is open to the public, although seating is limited.  This meeting will also be webcast. For more information see https://www.drugabuse.gov/news-events/meetings-events. This will be followed by a formal Request for Information on potential issues in such a study.  

Inquiries

Please direct all inquiries to:

Gayathri J. Dowling, Ph.D.

Director, Adolescent Brain Cognitive Development (ABCD) Study

National Institute on Drug Abuse

Telephone: 301-443-4877

Email: gayathri.dowling@nih.gov