Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional) | RFA DA 19 015

Opportunity Information: Apply for RFA DA 19 015

The National Institutes of Health (NIH) funding opportunity RFA-DA-19-015 supports small businesses that want to build and test digital loyalty or reward-based technologies aimed at improving adherence to FDA-approved medications used to treat substance use disorders. The core idea is to develop a technology platform, often delivered through a mobile medical app/device setup or similar digital tools, that can reinforce consistent medication-taking behavior through structured incentives. These incentives are not meant to be one-off gift cards handed out manually; the program emphasizes rewards and behavioral contingencies that can be delivered in a self-sustaining way, meaning the system should be designed to operate reliably over time without requiring constant hands-on administration.

The grant uses the SBIR phased structure under the R41/R42 mechanism, with clinical trials described as optional depending on what is necessary to achieve the project goals. Phase I (R41) is focused on demonstrating feasibility and/or validating the device or platform. In practical terms, this usually means proving that the technology can accurately track relevant behaviors, function in real-world settings, and integrate the core reward/loyalty logic in a way that is usable and acceptable for the intended users. Phase II (R42) then scales up to test efficacy in a larger sample, moving beyond feasibility into a more rigorous demonstration that the platform actually improves outcomes. Across both phases, the main outcome the program cares about is medication adherence to FDA-approved pharmacotherapies for substance use disorders, so projects should be designed with adherence as the primary endpoint, not as an indirect or secondary measure.

A key program expectation is that the technology includes a provider-facing component. This front-end interface should allow treatment providers (or clinic staff) to monitor participant progress and manage reward delivery in a structured way. The platform can incorporate advanced or novel features, and the announcement explicitly welcomes tools such as automated tracking systems, real-time measurements of patient progress, verification of medication intake, and momentary assessment approaches. The intent is to support technologies that go beyond basic reminders by pairing measurement with meaningful reinforcement, ideally in a manner that can adapt to patient behavior and maintain engagement over time.

Another important aspect is the regulatory trajectory. The funding announcement states that data generated through these studies should be usable to support a future FDA 510(k) submission, with the goal of seeking clearance as an FDA-cleared device. That implies applicants should be thinking early about design controls, validation, documentation, and the kind of performance evidence that would map onto a device clearance pathway. In other words, the research is not only about publishing results; it is also meant to move a product toward commercialization and regulatory acceptance.

Eligibility is restricted to small businesses, consistent with SBIR expectations. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components may be allowed under NIH policy definitions, meaning a U.S.-based applicant might still be able to include certain foreign collaborations if they meet NIH requirements and are justified appropriately. The opportunity is categorized as discretionary grant funding within education and health activities (CFDA 93.279), administered by NIH, with an original closing date listed as December 14, 2018, and a creation date of September 18, 2018.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - 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 2018-09-18.
• Applicants must submit their applications by 2018-12-14. (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 19 015

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