University of Vermont Investigators Receive New Federal Research Award

University of Vermont (UVM) Distinguished Professor Stephen T. Higgins, PhD, director of the Vermont Center on Behavior and Health (VCBH), has received a notice of award from the National Institute on Drug Abuse for a UG3/UH3 application to further evaluate a smartphone-based digital financial-incentives (FI) treatment for perinatal smoking cessation. The UG3/UH3 mechanism has investigators work in coordination with the Food and Drug Administration (FDA) to conduct efficacy (UG3) and effectiveness (UH3) randomized clinical trials of new digital healthcare interventions. Should trial outcomes support the effectiveness of the intervention, the treatment can be designated an FDA approved digital intervention. This digital intervention developed in collaboration with DynamiCare Health (https://www.dynamicarehealth.com) previously received FDA Breakthrough Device designation based on preliminary trials using national samples of perinatal women. 

Addressing a Rural Healthcare Disparity

Cigarette smoking remains the leading preventable cause of poor pregnancy outcomes in the United States, resulting in serious adverse maternal and infant health outcomes. Unfortunately, this problem disproportionately impacts rural communities, where pregnant women are more likely to smoke through pregnancy than more urban or suburban peers and often have limited access to evidence-based smoking-cessation treatments.

"Scaling traditional, clinic-based perinatal smoking cessation programs in the U.S. has hit a critical bottleneck due to widespread rural hospital closures and a lack of on-site smoking-cessation services," explained Dr. Higgins, the originator of this financial-incentives intervention for perinatal smoking cessation wherein patients are rewarded with vouchers or gift certificates for retail items for abstaining from substance use. "By transitioning to a remote digital therapeutic, we can bypass the brick-and-mortar limitations of local healthcare facilities and deliver life-saving support straight into the hands of the mothers and their infants who need it most."

Through the smartphone application, participants remotely submit videos of themselves performing salivary cotinine (nicotine metabolite) tests. The software permits verification of maternal smoking status and timely deposit of financial rewards directly onto a secure, managed debit card that blocks non-essential spending on items like alcohol, cannabis, or firearms.

A Multidisciplinary Research Effort

This multidisciplinary research effort features a roster of successful VCBH collaborators, including Co-Investigators Ira M. Bernstein, MD (UVM, Department of Obstetrics, Gynecology, and Reproductive Sciences), Michael J. DeSarno, MS (UVM Biomedical Statistics Research Core), Sarah H. Heil, PhD (UVM, Departments of Psychiatry and Psychological Science), and Donald S. Shepard, PhD (Brandeis University, Health Economist).

Start Time

Initial experimental enrollment protocols are slated to commence early summer 2026, utilizing national remote recruitment strategies that the team successfully adapted and refined during prior remote randomized clinical trials.