Solutions to enable diagnosis and treatment of adverse health consequences of non-disordered drug use (R43/R44 - Clinical Trial Optional)

The National Institute on Drug Abuse (NIDA) invites applications for the Small Business Innovation Research (SBIR) program to develop affordable and accessible solutions to address health issues stemming from non-disordered drug use. Non-disordered drug use involves drug use without meeting the DSM-5 criteria for substance use disorder. This funding opportunity (R43/R44) supports small business projects aiming to prevent, diagnose, or treat health issues related to non-disordered drug use, such as hypoxia-induced brain injuries from opioid overdose, cardiovascular complications from stimulant use, and health risks from maternal drug exposure. Additionally, the initiative encourages projects targeting adverse effects from cannabis, synthetic cannabinoids, xylazine, and other novel drugs. Funding is structured into two phases: Phase I for establishing project feasibility with a budget limit of $400,000 and a maximum duration of one year; and Phase II, allowing further research and development, with a budget ceiling of $3,000,000 over three years. For fast-track projects, Phases I and II can be proposed concurrently, contingent upon meeting milestones that demonstrate feasibility. NIDA intends to commit up to $2 million in fiscal year 2025 for approximately 2-5 awards, depending on project types and funding availability. The project must align with FDA-regulated pathways, with applicants required to outline their plan for FDA premarket approval or investigational filings as appropriate. Eligibility is limited to U.S.-based small business concerns that are more than 50% directly owned by U.S. citizens, permanent residents, or eligible U.S. entities. Foreign entities are excluded, although U.S.-based applicants may subcontract specific tasks internationally if critical to project success. Prospective applicants are encouraged to engage with FDA resources early to align their project’s regulatory path and consult the NIH's Research Methods Resources for clinical trial designs if needed. Evaluation of applications will include a merit review with criteria assessing the project’s significance, the technical expertise of the team, innovation, research approach, and business environment. For clinical trial projects, additional factors such as study design, recruitment strategy, and data management will be considered. Applicants are required to provide specific, measurable milestones for each phase, and fast-track applications must include go/no-go criteria to justify Phase II progression. In cases involving prior products, applicants should demonstrate how adapting the product addresses unique challenges associated with non-disordered drug use. Applications must comply with NIH’s electronic submission process through Grants.gov, with a due date of December 2, 2024. Applicants are encouraged to submit proposals early to allow time for error correction. Registrations in the System for Award Management (SAM), eRA Commons, and SBA Company Registry are mandatory for eligibility. Awards are contingent upon NIDA's internal review and the availability of funds, with project start dates anticipated by July 2025 following advisory council recommendations.