Christopher Shaffer, PharmD, assistant professor of Pharmacy Practice and Science, is a principle investigator on the UNMC team awarded an NIH cooperative agreement to study the hormone oxytocin as a treatment for an important psychiatric condition of adolescence. Dr. Shaffer and fellow principle investigator, Soonjo Hwang, MD, associate professor of Psychiatry, are leading this three-year, $2.2 million study, which began in September. The research is funded by the National Institute of Mental Health (NIMH).
Two Boystown National Research Hospital neurobiologists, James Blair, PhD, and Stuart White, PhD, are co-investigators.
This project, also recently highlighted in UNMC Today, seeks to characterize the ways therapeutic oxytocin interacts with adolescent patients who have been diagnosed with irritability (several conditions that involve increased propensity to exhibit anger). Underlying the project is the hypothesis that oxytocin reduces irritability by modulating brain regions that participate in the acute threat response system.
The study team plans to enroll 80 patients 14-18 years of age who will receive varying doses of oxytocin, within a range known to be safe. They will explore the mechanism of action using task-related and resting-state functional MRI (fMRI). The Pediatric Pharmacology Research Unit, under Dr. Shaffer’s direction, will analyze oxytocin levels in blood and saliva with state-of-the-art mass spectrometry methods.
“Per the NIMH, this is the first pediatric pharmacodynamic study that has been funded by the agency,” Dr. Shaffer remarked. “The goals of this study are to not only describe the pharmacokinetics of intranasal oxytocin, but to correlate these concentrations to blood oxygen level-dependent changes as monitored by functional MRI.”
As a cooperative agreement (U01), this study features ongoing involvement by NIMH, the sponsoring NIH institute. Dr. Shaffer explained, “We meet weekly with the NIMH team to review and strengthen the study as part of the cooperative agreement. Due to the innovative nature of this study, we are fortunate to work with some very good scientists at the NIMH.”
When asked if this project may open doors for future pediatric pharmacology research, Dr. Shaffer responded enthusiastically. “Absolutely. We are very excited to receive this NIH award, especially this early in our partnership with CHRI. We are currently involved in a number of pharmacokinetic and pharmacodynamic studies, as well as a couple of pharmacogenomic studies.
“The establishment of the Pediatric Clinical Pharmacology Program should be able to assist investigators at UNMC and beyond with pediatric pharmacologic research. Rather than sending samples for analysis to other institutions or the pharmaceutical industry, we have the technical and scientific expertise to conduct this research here at UNMC and Children’s.”
by Matthew Sandbulte, CHRI Grant & Scientific Writer | October 8, 2020