The National Institute on Drug Abuse (NIDA) is encouraging Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research projects for developing tools for distributed clinical trials for substance use disorders (SUD). The aim is to facilitate remote data collection, transfer, handling, and storage to support distributed clinical trials for SUD, ultimately increasing participation, diversity, and retention in these trials.
Decentralized Clinical Trials for SUD
Traditional SUD clinical trials often require in-person visits for recruitment, enrollment, interventions, and data collection. These requirements can limit the diversity of participants due to factors such as travel time, work conflicts, transportation issues, childcare responsibilities, and the stigma associated with participating in a SUD trial. Decentralized clinical trials (DCTs) offer a solution by converting most visits into telehealth or phone calls, utilizing remote monitoring equipment, and enabling medication dispensing at local facilities. This approach can solve commuting problems, reduce time off work, and mitigate privacy concerns.
Gaps in Current DCT Technologies for SUD
Despite the potential benefits, there are gaps preventing the widespread use of DCTs in the SUD field. Existing wearable sensors for physiological measurement are not frequently used in SUD trials and may require further validation. Many devices lack software interfaces conforming to the Fast Healthcare Interoperability Resources (FAIR) standard for data transmission. Furthermore, there is a lack of wearable or home-use detection devices capable of measuring the concentration of substances of interest in SUD trials, such as methadone, buprenorphine, illicit drugs, and their metabolites.
Research Objectives and Funding Details
This funding opportunity seeks the development of tools for DCTs to increase participation, diversity, and retention in SUD clinical trials. Research areas include wearable devices for measuring opioids, stimulants, and other misused drugs; devices with socially acceptable form factors; software solutions for handling data streams; and systems capable of operating with low-bandwidth services. NIDA intends to commit an estimated total of $3M in FY 2025 to fund approximately 5-10 awards across RFA-DA-25-051 and RFA-DA-24-052, depending on the mix of application types. Budgets up to $306,872 total costs for Phase I and up to $2,045,816 total costs for Phase II may be requested. Award periods may not exceed one year for Phase I and three years for Phase II.
Eligibility and Application Information
Only United States small business concerns (SBCs) are eligible to apply. The primary employment of the Program Director/Principal Investigator (PD/PI) must be with the small business concern at the time of award and during the project. Applications can be submitted as Phase I, Fast-Track, or Direct to Phase II. The application deadline is March 15, 2024. Applicants are encouraged to review the guidelines and requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards.
Words Matter: Preferred Language
NIDA encourages the use of preferred language that accurately describes addiction and substance use without perpetuating stigma and bias. Person-first language, such as "person with a substance use disorder" instead of "substance abuser," is recommended. NIDA also encourages using the term "medications for opioid use disorder" (MOUD) instead of "medication-assisted treatment" (MAT) or "opioid substitution therapy" (OST).
