HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial Clinical Site

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PROJECT SUMMARY/ABSTRACT The University of Arkansas for Medical Sciences (UAMS) will be a clinical site for the HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial-Clinical Sites (UG1), RFA-HD-21-031. Arkansas (AR) is a rural state with the second highest opioid prescription rate in the nation and is in the top 3 states nationwide for opioid prescriptions to pregnant mothers. Additionally, AR has the second highest number of Adverse Childhood Experiences in the nation, thus making this an ideal site to study the effects of opioid use in a state with other environmental stressors. Recruitment will be from a robust Women's Mental Health Program, which saw 899 pregnant women with opioid use disorder last year, the general obstetrical clinic, and the 64 bed academic Neonatal Intensive Care Unit (NICU) at UAMS. Innovative strategies for recruitment will include investigator attendance at prenatal classes and a Community Advisory Board, while retention will be bolstered by frequent electronic communication, updated contact information, financial and scheduling incentives. Follow-up will be performed at the Arkansas Children's Hospital Research Institute in a state of the art Pediatric Clinical Research Unit. Compliance for follow-up is anticipated to be challenging for this trial, so innovative strategies to encourage compliance will include monetary incentives, ease of scheduling, and case managers to arrange free travel, meals, and other needs for participants. Parents will also be given results of their psychological exams to encourage compliance. This project is well supported by the Translational Research Institute (TRI), home of a Clinical and Translational Science Award. This site has extensive experience conducting multicenter trials and is currently involved in two similar trials, which will be completed by the time this site will begin enrolling patients assuring this site will be ready to begin enrollment after funding. This site also has extensive experience in opioid research and will actively contribute to protocol development. Major strengths of this site include experience in pk/pd modeling, a robust telemedicine program to bolster awareness of the study statewide, and a Center for Implementation Science to implement evidence based weaning medication. This site has a large diverse clinical population with an average of 3450 annual deliveries, approximately 10% of the state's annual deliveries, with 273 opiate exposed neonates and 49 pharmacologically treated newborns annually. There are 53% white, 33% African American and 11% Hispanic mothers who deliver annually at UAMS. Public insurance accounts for 81% and private insurance accounts for 16% of all newborn admissions. This site has an excellent track record of participation in multicenter trials (12 trials are open currently) and a robust scholarly publication record. The assembled group of researchers at this site will contribute to the analysis, interpretation, and publication of results. The environment at this site is supportive of this initiative, and leadership will provide the support, protected time, and the infrastructure to successfully complete the study.