Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional) | RFA DA 19 014

Opportunity Information: Apply for RFA DA 19 014

The grant opportunity "Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)" (Funding Opportunity Number RFA-DA-19-014) is a National Institutes of Health (NIH) small business funding announcement aimed at improving how consistently patients take FDA-approved medications for substance use disorders. The central idea is to develop and evaluate digital loyalty or reward-based technologies, such as mobile apps, app-connected devices, or other digital platforms, that function as a combination product to boost medication adherence. Rather than focusing on creating new medications, this program focuses on building technology-enabled incentive systems that make it more likely people will stay on prescribed treatment, since adherence is often a major barrier to successful outcomes in substance use disorder care.

The announcement uses the SBIR phased structure (R43/R44). Phase I (R43) is intended to prove feasibility and/or validate the technology, meaning applicants should demonstrate that the proposed platform can realistically work as intended in the target setting and population. This includes showing that the core components (such as tracking, reward delivery, and provider-facing monitoring) are functional and that the approach is plausible for supporting adherence. Phase II then scales up to test efficacy in a larger sample, moving beyond feasibility into stronger evidence that the reward-based platform actually improves adherence outcomes when used under more robust study conditions. Clinical trials are optional under this funding mechanism, which gives applicants flexibility in how they design their development and evaluation pathway, but the overall expectation is that the work will generate meaningful evidence about performance and impact.

A key feature of this opportunity is that the primary endpoint is adherence to FDA-approved medications for substance use disorders. In practice, this means the technology and the study design should be built around measuring and improving whether participants take their prescribed pharmacotherapy as directed. The program is specifically interested in reward and contingency systems that can be delivered in a self-sustaining manner, rather than relying on a model that is difficult to maintain after the study ends. In other words, the technology should support incentives and reward delivery in a way that can realistically continue in real-world treatment environments, including consideration of cost, logistics, and operational burden.

The FOA also emphasizes that the platform should include a front-end interface for treatment providers. This provider-facing component is expected to let clinicians or care teams monitor patient progress and manage reward delivery, which ties the technology into clinical workflows rather than keeping it purely patient-facing. The technology may incorporate a wide range of novel digital features, including automated tracking tools, real-time assessments of patient progress, confirmation or tracking of medication intake, and momentary assessment capabilities (for example, brief in-the-moment check-ins that capture cravings, mood, risk contexts, or other clinically relevant signals). The common thread is that these features should support timely, data-informed reinforcement and better adherence support.

Another major point in the announcement is the regulatory trajectory. The NIH indicates that data generated from the Phase I and Phase II studies are intended to support a future 510(k) submission, with the goal of seeking FDA clearance as a medical device. That signals that applicants should think early about device classification, intended use claims, validation plans, documentation, and the type of evidence FDA would expect for clearance. In practical terms, the program is not just funding an academic-style pilot; it is pushing toward a product development pathway where clinical and technical data contribute to an FDA device clearance strategy.

In terms of who can apply, eligibility is limited to small businesses, consistent with the SBIR/STTR-style framework (the FOA lists "Small businesses" under eligible applicants). Non-U.S. entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the announcement notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed, which typically means certain discrete elements of the project could involve foreign collaboration or activity if appropriately justified and compliant with NIH policy, even though the applicant organization itself must be U.S.-based and eligible.

Administrative details included in the source information indicate this is a discretionary grant opportunity in the education and health activity area (CFDA 93.279) managed by NIH, with an original closing date of December 14, 2018, and a creation date of September 18, 2018. Overall, the funding opportunity is designed to push forward practical, scalable, and clinically integrated digital reward systems that measurably improve adherence to substance use disorder pharmacotherapies, while also generating the kind of validation evidence needed to move toward FDA-cleared device status.

• 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 (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 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.

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