Federal Cooperative Agreement Summary

The University of Vermont & State Agricultural College received a $732,462 Cooperative Agreement from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279), awarded May 15, 2026, with completion targeted for April 30, 2028. This award supports Phase 2 (UG3) and Phase 3 (UH3) randomized controlled trials (RCTs) examining a smartphone-based digital financial incentives (FI) intervention for perinatal smoking cessation, developed in collaboration with DynamiCare Health Inc. The digital intervention aims to achieve FDA approval as a digital therapeutic and addresses a critical gap in smoking-cessation services, particularly for underserved populations in rural regions where traditional clinic-based cessation interventions are unavailable.

The project builds on prior Phase 2 RCT evidence demonstrating that adding digital FI to best-practice interventions (BP+FI) increased cessation odds four-fold compared to best practices alone, with mean incentive payouts of $331 per participant across a nine-month intervention period. The intervention previously received FDA Breakthrough Device Designation. Through this funding, UVM will conduct expanded RCTs in collaboration with the FDA to generate evidence supporting regulatory authorization of the digital therapeutic, with the ultimate goal of improving perinatal smoking-cessation outcomes and reducing preventable adverse pregnancy outcomes and related health complications.