Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R43/R44 - Clinical Trial Optional) | RFA DA 19 033

Opportunity Information: Apply for RFA DA 19 033

The National Institutes of Health (NIH) funding opportunity titled "Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R43/R44 - Clinical Trial Optional)" (Funding Opportunity Number RFA-DA-19-033; CFDA 93.279) is a Small Business Innovation Research (SBIR) grant mechanism aimed at pushing forward practical, clinically relevant virtual reality (VR) technologies for substance use disorder (SUD) treatment and related needs. The overall goal is to support the development and evaluation of VR-enhanced tools that can strengthen evidence-based treatment and recovery support for SUDs, offer treatment alternatives for people experiencing chronic pain (particularly where pain and substance misuse intersect), and/or function as next-generation clinical research tools that use rich behavioral and physiological data captured during VR experiences. A notable emphasis is on leveraging VR-generated data to identify "digital markers" that can help model SUD and common comorbid mental health disorders, potentially improving assessment, prediction, and personalization of care.

This opportunity is structured as a phased SBIR pathway: Phase I under the R43 mechanism and Phase II under the R44 mechanism. Phase I is focused on establishing feasibility and/or validation of the proposed VR device or platform. In practical terms, this means applicants are expected to demonstrate that the VR approach is workable, technically sound, and credible for its intended clinical or research use case, such as craving reduction, cue exposure interventions, skills training, relapse prevention support, pain management alternatives, or objective measurement of clinically meaningful behaviors within a controlled virtual environment. Phase II then builds on those Phase I results by testing the efficacy of the VR platform in a larger sample, moving beyond feasibility to a more robust evaluation of outcomes. While the announcement notes that clinical trials are optional, the intent clearly supports rigorous evaluation when appropriate, especially for tools positioned as interventions.

A key commercialization and regulatory thread in the announcement is that, for VR digital therapeutics, the data produced through these Phase I and Phase II studies are expected to support a future FDA 510(k) submission for medical device clearance. This signals that NIH is looking for products with a credible pathway to real-world deployment in healthcare settings, and that applicants should be thinking early about clinical validation, risk, intended use claims, and how study endpoints and documentation can later align with regulatory expectations. Put simply, the program is not only interested in novel VR experiences, but in VR technologies that can be validated, measured, and realistically advanced toward implementation as regulated healthcare tools when they function as therapeutics.

Eligibility is limited to small businesses, consistent with the SBIR program. The opportunity also specifies important restrictions regarding foreign involvement: non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined under the NIH Grants Policy Statement may be allowable in some cases, meaning certain project activities conducted outside the U.S. could be permitted if they meet NIH policy requirements and are justified, but the applicant organization itself must be an eligible U.S. small business and must follow the solicitation's rules on where work is performed.

From an administrative standpoint, the opportunity is categorized as a discretionary grant within the Education and Health funding activity category, administered by NIH. The original closing date listed for the announcement is March 20, 2019, and the notice was created on January 11, 2019. The provided source information does not include an award ceiling or the number of expected awards, indicating those details were either not specified in the excerpt or were variable depending on available funds and application quality. Overall, the announcement is best understood as a targeted SBIR push to translate VR from a promising concept into validated, scalable tools that can measurably improve SUD treatment and recovery outcomes, provide safer or more effective options for chronic pain management, and enable new types of data-driven clinical research through digital markers captured during immersive VR experiences.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R43/R44 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2019-01-11.
• Applicants must submit their applications by 2019-03-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA DA 19 033

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