Children born to mothers addicted to opioids suffer through withdrawal in their first few weeks of life. Morphine is commonly used in Neonatal Intensive Care Units (NICU) to alleviate symptoms while the kids are weaned from drug dependency. This typically takes two to four weeks, all the while the children are kept in the NICU.
A new electrical device, called Roo from Spark Biomedical, is now undergoing testing, that may help shorten the weaning time to ten days or less by stimulating the cranial nerve branches on and near the ear. The therapy it administers, called Transcutaneous Auricular Neurostimulation (tAN), reportedly motivates the brain to release endorphins that bind to opioid receptors, and thereby reduce the brain’s hunger for opioids. This technology was already successfully tested in a clinical trial on adult patients suffering from opioid withdrawal, so the same gentle-to-administer therapy was attempted with neonates as well.
“This neurostimulation is giving the brain a little bit of a boost of its own endogenous opioids to perhaps reduce the need for exogenous morphine, which has all these dangerous side effects when delivered for prolonged periods of time in this critical neurodevelopmental window,” said Bashar Badran, Ph.D., an assistant professor at Medical University of South Carolina (MUSC).
Bashar and a team of clinicians that specialize in managing opioid dependent newborns at MUSC tested the Roo device on three children born suffering from opioid withdrawal symptoms. This involved evaluating the kids on the Finnegan scale, which measures neonates’ withdrawal symptoms, then administering tAN therapy and doing another Finnegan evaluation. Subsequently, morphine therapy was administered using existing standard of care protocols. In a remarkable result, in a trial which will involve more participants, the three children tested so far were weaned off morphine in an average of ten days. Given that an average NICU stay for an opioid dependent child in the United States is 21 days, the early results from the study are very promising.
“When you see babies who are withdrawing from opioids, you immediately feel terrible for them. They are in a lot of distress. They are jittery, crying constantly, hard to soothe and console, and may have fast breathing and vomiting. This open-label clinical trial is designed to show that a seven- to 10-day morphine wean is safe and achievable with tAN, which would be a significant improvement over standard of care,” said Dorothea Jenkins, M.D., a professor of pediatrics at the Medical University of South Carolina, in an announcement. “With three infants successfully completing the protocol, we are encouraged that this therapy may offer benefit.”