RESEARCH TRIANGLE PARK, N.C. — RTI International, a nonprofit research institute, received National Institutes of Health (NIH) cooperative agreement awards in September under The Helping to End Addiction Long-term, or the NIH HEAL Initiative. These awards are aimed at gaining a better understanding of impact of the opioids on infants, and will bolster efforts to prevent opioid misuse among at-risk populations.
RTI will support the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Program, which aims to inform the clinical care of infants exposed to opioids in the womb. As the Data Coordinating Center (DCC) for ACT NOW, RTI will work with clinical investigators across the country to conduct the following studies:
- The ACT NOW Eat, Sleep, Console (ESC) Clinical Trial will test ESC for treating infants with NOWS without using drugs.
- The ACT NOW Trial to Shorten Pharmacologic Treatment of Newborns with NOWS (Weaning Trial) will compare rapid with slow opioid weaning among neonates with NOWS treated with morphine or methadone.
- The ACT NOW Longitudinal Study will study the impact of antenatal opioid exposure and NOWS on childhood brain structure and connectivity and on medical, developmental and behavioral trajectories in early childhood.
“Little is known about the long-term effects of prenatal opioid exposure. These awards will help us fill in these gaps in knowledge and help researchers and medical professionals design more effective early interventions to help the youngest and most vulnerable members of our society,” said Carla M. Bann, PhD, project lead for the ACT NOW Longitudinal Study and RTI fellow in statistics and psychometrics with deep expertise in maternal and child health.
Abhik Das, PhD, project lead for the two ACT NOW clinical trials and Senior Biostatistician, added: “There are few standard, evidence-based treatments for NOWS. These trials will help develop an evidence base for the clinical care of infants with NOWS that informs medical practice and health policy.”
Additional work awarded last month called the Coordinating Center to Support NIDA Preventing Opioid Use Disorder in Older Adolescents and Young Adults will support the Prevention HEAL initiative. This focuses on establishing the evidence base for interventions and strategies to prevent initiation of opioid misuse and development of Opioid Use Disorder (OUD) in at-risk older adolescents and young adults.
“This award addresses the need for preventive interventions among marginalized people in health care and justice-involved settings,” said Phillip W. Graham, DrPH, senior director at RTI’s Center on Social Determinants, Risk Behaviors and Prevention Science and project lead of this award. “It will leverage RTI’s expertise in evaluation design; data collection, management and analysis; and implementation science to reduce the grip of this epidemic on our teens and young adults.”
RTI’s awards are among 375 grant awards across 41 states made by the NIH in fiscal year 2019 to apply scientific solutions to reverse the national opioid crisis.
The NIH HEAL Initiative aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose and achieve long-term recovery from opioid addiction.
“It’s clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids,” said NIH Director Francis S. Collins, M.D., Ph.D., who launched the initiative in early 2018. “This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis.”