The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code.