WASHINGTON, D.C. — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $10 million to fund two new comparative clinical effectiveness research (CER) studies on medication-assisted treatment (MAT) for pregnant women with opioid use disorders.

The prevalence of opioid use disorders (OUD) has increased dramatically among pregnant women in parallel with the current opioid epidemic. MAT, which combines maintenance medication (methadone or buprenorphine) with psychosocial services, is an evidence-based, clinically effective treatment for pregnant women with OUD. Compared to methadone, buprenorphine has a more favorable safety profile and improved birth outcomes, including reduced incidence and severity of neonatal abstinence syndrome.

These studies focus on strategies to identify the most effective ways to provide the best care and support to expectant and new mothers with opioid use disorder, to improve outcomes for both mothers and their infant children. The newly approved awards are:

• $5.3 million for a Dartmouth College project that will compare the outcomes of women receiving prenatal care in practices that also provide MAT with those of women who receive referrals to specialty care for MAT from their providers. Researchers will study outcomes identified by the women and their care teams, such as pregnancy complications, infant treatment for neonatal withdrawal, women’s continued opioid and other substance use, and mothers’ engagement in MAT.
• $4.9 million for a University of Kentucky-based project to compare two delivery models for comprehensive treatment for perinatal opioid use disorder to rural populations. Women will receive prenatal care and MAT through their community-based providers. In addition, they will receive an evidence-based curriculum either through in-person group sessions led by a perinatal nurse facilitator and a peer support specialist, or through telemedicine consultations with specialists in high-risk pregnancy, addiction care, substance use counseling and neonatology. Researchers will compare outcomes including the long-term success of the women’s recovery and their babies’ health.    

“We clearly need more evidence-based information about more effective ways to treat addiction,” said PCORI Executive Director Joe Selby, MD, MPH. “We at PCORI are working to address a number of gaps in the field of opioid research, such as treatments for vulnerable populations like pregnant women, as well as nonopioid treatment options for pain management and strategies to help patients understand the risks and benefits of opioids.”

To date, PCORI has invested $252 million in 65 patient-centered CER studies on substance use disorders and pain management. These include 13 studies specifically focused on opioid use.

Details of all studies approved by the Board can be found on PCORI’s website. The new awards were approved pending a business and programmatic review by PCORI staff and issuance of formal award contracts. With these latest awards, PCORI has invested $2.1 billion to fund more than 400 patient-centered CER studies and to support other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.

####

About PCORI

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.