A new clinical trial at Marshall may provide help for babies born after being exposed to opioids using a non-opioid medicine.
Twenty-four eligible newborns at the Marshall Health Network’s Hoops Family Children’s Hospital will participate in the second cohort of clinical trials.
Medical research teams working through the Marshall University Joan C. Edwards School of Medicine and Marshall Health Network aim to evaluate the safety and efficacy of oral lofexidine. This is a non-opioid investigational medication meant for newborns who suffer from neonatal opioid withdrawal syndrome (NOWS) or neonatal abstinence syndrome (NAS) due to prenatal exposure to opioids.
Lofexidine is an alternative to the adverse effects of opioid medications such as morphine or methadone. Researchers say unlike opioids, lofexidine does not produce euphoria, the potential for addiction or prolong the withdrawal process in newborns.
The randomized, controlled clinical trial will enroll up to 24 eligible newborns at Hoops Family Children’s Hospital at Cabell Huntington Hospital. Hoops houses a Neonatal Therapeutic Unit (NTU), which provides specialized, comprehensive care for infants prenatally exposed to opioids.
The study will evaluate the duration of treatment, need for rescue medication and length of hospital stay.
In previous clinical studies of lofexidine in adults, the most common adverse events were orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth.
Enrollment in the clinical trial is ongoing and targeted to be completed by the end of 2024. Results from this study will be used to support
dosing recommendations in neonates and to inform further studies in the pediatric patient population.
Marshall Health Network spokespeople say Hoops is the first hospital in the country to offer this non-opioid investigational treatment option for NOWS newborns.