This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.

Inclusion Criteria:

• Pregnant women with OUD and their infant
• Currently on BUP/METH for OUD
• Enrolled in prenatal opioid maintenance program
• Age >18 years
• Singleton pregnancy
• Planned delivery at UPMC's Magee Womans Hospital
• Positive opioid urine screen results

Exclusion Criteria:

• Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
• HIV or AIDS
• Known major fetal congenital abnormalities

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. We expect the effective sample size of evaluable patients will be 200 with longitudinal data.

We intend to share data that is generated from the grant at the earliest opportunities throughout this research project in counsel with our intellectual property lawyers. The details of the risk prediction algorithms will remain proprietary and will be protected as a trade secret.

Data will become available after completion of the two-year enrollment period.

This information will be held in a commercial cloud-based data portal with a password and encrypted security, such as commercial sources BOX, Dropbox, Engnyte, and Sharepoint. Access to the electronic portal will only be provided after the receiving party has signed a confidentiality agreement. The data will not be downloadable but rather only allow for viewing from the cloud-supported site. This is the process used during corporate due diligence in determining the potential to invest and is an industry-accepted approach. This approach will be used for potential investors and additional collaborators on future projects.