The National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH) has announced a funding opportunity for small business entities to develop diagnostic and treatment solutions addressing adverse health outcomes from non-disordered drug use. Non-disordered drug use, distinct from substance use disorder (SUD), involves using a substance without meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for SUD. This funding initiative seeks innovative solutions to improve health outcomes in this context, including solutions for opioid, cannabis, cocaine, and methamphetamine use, and related health risks such as hypoxia-induced brain injury, stimulant-induced cardiovascular issues, and maternal and fetal health complications from drug exposure during pregnancy.

Eligible applicants include U.S.-based small businesses, which may apply for Phase I or Fast-Track Small Business Technology Transfer (STTR) grants under the R41/R42 mechanism. Phase I aims to establish technical feasibility, while Phase II focuses on advancing technology towards commercialization. This phased approach encourages private-sector development of products that improve public health. The maximum budget is $400,000 for Phase I (up to one year) and $3,000,000 for Phase II (up to three years), with NIDA projecting 2-3 awards in fiscal year 2025, depending on the availability of funds and the quality of submissions.

Applicants are encouraged to propose FDA-regulated pharmacological treatments and medical devices, including diagnostic software, which align with regulatory pathways toward FDA approval. Priority areas include solutions to prevent and treat hypoxia-related brain injury from opioid overdose, stimulant-induced cardiovascular complications, and health consequences of synthetic cannabinoids and novel substances like xylazine. Additional areas include maternal and fetal health effects from drug exposure during pregnancy, acute endocarditis from IV drug use, and soft-tissue injuries from drug injection. Applicants with products targeting other indications can apply if they demonstrate potential for repurposing these products to address health impacts of non-disordered drug use.

The application process requires a detailed project proposal with specific milestones, emphasizing commercial viability and adherence to NIH and FDA regulatory standards. Fast-track applicants must provide distinct, measurable milestones for each project phase, along with go/no-go criteria for transitioning from Phase I to Phase II. Moreover, NIDA encourages early engagement with the FDA to confirm regulatory compliance, especially for medical devices. Required registration with various systems (SAM, eRA Commons, SBA Company Registry) must be completed before application submission, with applications strictly due by December 2, 2024.

Application review will assess factors such as significance, innovation, investigator expertise, approach, and environment. Additional review criteria for clinical trials include study design, data management, and statistical analysis. Applications must comply with specific NIH policies, including data management and human subjects’ protection standards. Selected applications will undergo scientific and technical merit review by NIDA, followed by advisory review by the National Advisory Council on Drug Abuse (NACDA), with final award announcements expected by July 2025.