Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional)

This grant is designed to encourage the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD), with a particular focus on opioid and stimulant use disorders. The ultimate aim is to have these COAs approved by the FDA as development tools for new treatments.

The grant will be awarded in two phases, using the UG3/UH3Phased Innovation Awards Cooperative Agreement process. Applicants should develop a comprehensive COA plan that addresses both phases.

The first UG3 phase lasts a two-year period and by the end, all proposed operational milestones must be achieved. Once the National Institute on Drug Abuse (NIDA) confirmed the successful completion of the UG3 phase, the project will move on to the UH3 phase, which will be funded for an additional three years.

The overarching goal of this funding opportunity is to increase the number of FDA-approved COAs for use in the development of treatments for SUDs. Successfully meeting this goal should speed up the process of delivering new treatments for substance use disorders.

It should be noted that all applications need to include a Plan for Enhancing Diverse Perspectives (PEDP). Any applications without a PEDP will be deemed incomplete and therefore withdrawn. Applicants are urged to review the provided guidance for creating an effective PEDP.