Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

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The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD, although there are other pathways for dissemination of this class of intervention. The primary objective of this FOA is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications.