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

Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The opportunity is titled "Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders (R43/R44 - Clinical Trial Optional)."

What is the Funding Opportunity Number (FON) and CFDA listing?

The Funding Opportunity Number is RFA-DA-19-033, and the CFDA number listed is 93.279.

Which agency is offering this grant?

This is a National Institutes of Health (NIH) funding opportunity.

What type of grant mechanism is this?

This opportunity uses the Small Business Innovation Research (SBIR) mechanism with a phased pathway: Phase I under R43 and Phase II under R44.

What is the overall goal of the program?

The goal is to support the development and evaluation of practical, clinically relevant virtual reality (VR) technologies that can strengthen evidence-based treatment and recovery support for substance use disorders (SUDs), provide treatment alternatives relevant to chronic pain (especially where pain and substance misuse intersect), and/or serve as next-generation clinical research tools using rich behavioral and physiological data collected during VR experiences.

What kinds of VR projects does NIH appear to want to fund under this announcement?

Based on the description provided, NIH is aiming to advance VR-enhanced tools that are clinically meaningful and measurable. Example use cases mentioned include craving reduction, cue exposure interventions, skills training, relapse prevention support, pain management alternatives, and objective measurement of clinically meaningful behaviors in controlled virtual environments.

Is the focus more on novel VR experiences or clinically validated tools?

The emphasis is on VR technologies that can be validated and measured, and that have a realistic pathway toward real-world use in healthcare or research settings. The description specifically highlights clinically relevant development and rigorous evaluation when appropriate.

What does "Clinical Trial Optional" mean here?

The announcement states that clinical trials are optional. At the same time, it signals strong interest in rigorous evaluation when appropriate, particularly for tools positioned as interventions, and it describes Phase II as including efficacy testing in a larger sample.

What is expected in SBIR Phase I (R43) for this opportunity?

Phase I is focused on establishing feasibility and/or validation of the proposed VR device or platform. In practical terms, applicants are expected to show the approach is workable, technically sound, and credible for its intended clinical or research use case.

What is expected in SBIR Phase II (R44) for this opportunity?

Phase II is intended to build on Phase I results and test efficacy in a larger sample. The emphasis shifts from feasibility to a more robust evaluation of outcomes.

How does the opportunity describe the use of VR data and "digital markers"?

A notable emphasis is on leveraging VR-generated behavioral and physiological data to identify "digital markers" that can help model SUD and common comorbid mental health disorders. These markers could support improved assessment, prediction, and personalization of care.

What does the opportunity say about commercialization and real-world deployment?

The description frames this as a targeted SBIR push to translate VR from a promising concept into validated, scalable tools that can measurably improve outcomes and be advanced toward implementation in healthcare settings.

Is there any regulatory expectation mentioned for VR digital therapeutics?

Yes. For VR digital therapeutics, the description states that data produced through Phase I and Phase II studies are expected to support a future FDA 510(k) submission for medical device clearance.

What does the mention of FDA 510(k) imply for applicants?

It implies NIH is looking for products with a credible regulatory pathway. Applicants are expected to think early about intended use, clinical validation, risk, and how study endpoints and documentation could align with future regulatory expectations.

Who is eligible to apply?

Eligibility is limited to small businesses, consistent with the SBIR program.

Are non-U.S. organizations eligible to apply?

No. The opportunity states that non-U.S. entities (foreign institutions) are not eligible to apply.

Can a U.S. organization apply if parts of the organization are outside the United States?

The opportunity states that non-U.S. components of U.S. organizations are not eligible to apply.

Are any activities outside the U.S. allowed at all?

The description notes that "foreign components" (as defined under the NIH Grants Policy Statement) may be allowable in some cases. That means certain project activities conducted outside the U.S. could be permitted if they meet NIH policy requirements and are justified, but the applicant organization must still be an eligible U.S. small business and must follow the solicitation's rules on where work is performed.

How is the funding opportunity categorized administratively?

It is categorized as a discretionary grant within the Education and Health funding activity category, administered by NIH.

What are the key dates listed for this opportunity?

The notice was created on January 11, 2019, and the original closing date listed is March 20, 2019.

Does the provided information list an award ceiling or expected number of awards?

No. The source information provided does not include an award ceiling or the number of expected awards, indicating those details were not specified in the excerpt or could vary based on available funds and application quality.

What problem areas does this funding opportunity specifically call out beyond SUD treatment?

In addition to SUD treatment and recovery support, the description highlights chronic pain as an important area, particularly where chronic pain and substance misuse intersect. It also highlights the potential to model common comorbid mental health disorders through VR-generated digital markers.

Does this opportunity support VR tools used for research, not just treatment?

Yes. The description includes VR platforms that can function as next-generation clinical research tools, especially those capturing rich behavioral and physiological data during VR experiences.

What is the "best understood" intent of the announcement, based on the description provided?

It is best understood as a targeted SBIR effort to move VR from concept to validated, scalable tools that can improve SUD treatment and recovery outcomes, provide safer or more effective options related to chronic pain management, and enable new types of data-driven clinical research using digital markers captured during immersive VR experiences.