R01DA053745

State-Level Opioid Policies and Policies That Regulate Substance Use During Pregnancy: A Mixed Methods Exploration of Their Effects on Maternal and Infant Outcomes

The opioid and overdose crisis in the United States (US) disproportionately affects women of childbearing age (15–44 years), particularly pregnant women and their newborns. It is estimated that 20% of pregnant women are prescribed opioids during pregnancy. States have enacted both general opioid policies, such as access to medication for opioid use disorder (MOUD), and policies specific to substance use during pregnancy. However, the effects of these policies on pregnant women's opioid use and newborn outcomes remain poorly defined. States' policy responses to prenatal opioid use vary widely, resulting in inconsistent approaches to pregnant women's opioid use.

In this mixed-methods project, we will apply a convergent parallel design to examine the separate and combined impacts and consequences of state opioid policies on pregnant women and their newborns using Medicaid and commercial insurance databases (MarketScan). Our aims are as follows:

1. Examine the separate effects of general and prenatal state opioid policies on pregnant/postpartum women and newborns. We will:
a) Systematically map all 50 states' prenatal opioid policies (2011–2020) to categorize policy variations and build a publicly available time-varying dataset.
b) Use this prenatal policy dataset and existing data on general opioid policies to explore the individual-level impact of general and prenatal opioid policies on opioid use disorder (OUD), MOUD access, and neonatal opioid withdrawal syndrome (NOWS) for pregnant women and their newborns.
c) Test for effect modification by maternal race/ethnicity and age.

2. Investigate the combined effects of general and prenatal state opioid policies on pregnant/postpartum women and their newborns (2011-2020). To move beyond the impact of single policies in isolation, we will:
a) Use a modified Delphi approach to create a time-varying taxonomy of each state's overall opioid policy climate relevant to pregnant women, ranging from penalizing to health-promoting, based on states' combination of prenatal and general opioid policies.
b) Explore the individual-level impact of states' overall policy climates on pregnant/postpartum women and newborns using the same outcomes and effect modification as Aim 1.

3. Explore how prenatal policy implementation affects daily life for pregnant women and their newborns. We will:
a) Apply the Consolidated Framework for Implementation Research (CFIR) to interviews with 60 key stakeholders across states that vary by their overall policy climate to explore multilevel drivers of prenatal opioid policy implementation and how variations in implementation affect maternal and newborn health.
b) Create an ethnographic cohort of 40 pregnant women who use opioids across states with four different prenatal policy climates (punitive, prosocial, mixed, inaction) and conduct three interviews with each over one year. We will explore how variations in prenatal opioid policy implementation affect how women navigate pre- and postnatal care, MOUD use, and state services.

Findings from this study will have concrete real-world impacts by describing the effects of state opioid policies on pregnant/postpartum women and their newborns. Additionally, it will identify intervention points and policy changes that promote maternal and infant wellbeing.

The Trustees Of Columbia University In The City Of New York

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

New York, New York 100323727 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 291% from $781,336 to $3,056,493.