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Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional)


Substance use disorder (SUD) clinical trials traditionally perform recruitment, enrollment, interventions, as well as information collection at the clinical trial sites. In-person visits at the sites are used for screening, assignment to interventions, treatment or other intervention, follow up, as well as collection of information from participants and entering it in a database. Some of the in-person site visits may also include dispensing of medications that are required to be taken in front of the staff, testing for the presence of investigational drugs and their metabolites in urine or other matrices, testing for illicit drugs, and measuring physiological parameters. Some trial designs may also include delivery of education or behavior modification therapies either to the patients or to the providers. Requirements for participants to be physically present at the study location may be limiting the diversity of the participants in the trials due to a variety of factors including, for example, time to travel to the center, loss of time from work, transportation issues, child and elder care responsibilities. The perception of stigma associated with participating in a SUD trial can also prevent participation. These factors often hamper engagement, recruitment, screening as well as retention in trials. In a survey of clinical trials participants, it was found that they most often dislike the location, the length of the visit and time commitment. The limitations for clinical trials described above could be alleviated by utilizing decentralized clinical trials (DCT). DCTs allow for most of the visits to be converted into telehealth visits and/or phone calls. The monitoring, when needed, is done with equipment delivered to the patient's house or at local clinical laboratories and/or health care providers. Medical staff can occasionally make house calls for procedures. Medication or devices for interventions may be dispensed locally. The data are transmitted securely over standard communication channels (e.g., via internet, phone, mail). Informed consent may be also obtained remotely via electronic signatures. This approach may solve the commuting problem and decrease the loss of time from work and home care issues. Medication deliveries, done via standard courier services in compliance with the relevant laws, obfuscate the type of delivered drug, which preserves privacy and may help reduce the stigma of being seen to receive medications for SUD treatment. DCT also allows recruitment of patients from states that have a low number of centers and areas that are too far from such centers (e.g., rural or some tribal areas). Still, there are gaps that prevent the utilization of DCT in substance use area. The existing wearable sensors for physiological measurement are infrequently used in SUD trials and may need further validation. Many of these devices do not have software interface conforming to Fast Healthcare Interoperability Resources (FAIR) standard through which the devices can transmit the data to the study center. There are no wearable or home-use detection devices on the market capable of measuring the concentration of substances of interest in SUD trials (e.g., methadone, buprenorphine, their metabolites, as well as the spectrum of illicit drugs and their metabolites). Existing test strips are designed to detect presence of drugs or metabolites, but do not quantify them. Most of the existing tests capable of quantification are intended for laboratory use. There is also a need of a comprehensive system that creates and stores trusted records to facilitate data movement via secure sharing and consent. Such a system should be able to seamlessly function in areas with less connectivity. The decreased number of in-person visits necessitates expanded use of all methods for remote communication (calls, emails, text messages, MMS messages, written communications via USPS, etc.), to support adherence to the protocol. Therefore, there is a need for a unified system capable to track and report all instances of communications with study participants, while alleviating the burden on the research staff. Importantly, such a system should be able to handle the communication streams from all different sources and merge the existing and new solutions for DCT in a functioning structure. Research Questions: This notice of funding opportunity (NOFO) solicits development of tools for DCT with the overall goal to increase participation, diversity and retention in SUD clinical trials. This may include, but is not limited to, the research and development of: Wearable devices for measurement of opioids, stimulants as well as other illicit or misused drugs and their metabolites that can be used in the diagnosis or treatment of SUD Devices for use in SUD trials with socially acceptable form factor and mode of use (size, shape, appearance and placement that does not attract attention or induce stigma) Software solutions capable of handling all data streams (both from devices and SUD study participants) and providing interface to existing data collection systems for clinical trials to ensure interoperability ( plug-and-play use ) System capable of operating with low-bandwidth services or asynchronously to support SUD trials in rural or tribal areas Words Matter Drug addiction is a chronic but treatable disorder with well-understood genetic and social contributors. The National Institute on Drug Abuse (NIDA) encourages preferred language that accurately describes addiction and substance use in all submitted materials without perpetuating stigma and bias. Research shows that using person-first language such as "person with a substance use disorder" instead of "substance abuser" or "addict" can reduce negative associations and punitive attitudes among clinicians and researchers. Instead, NIDA encourages the use of "addiction" or "substance use disorders" or other specific terminology, such as "opioid use disorders (OUDs)" or "cocaine use disorders". In addition to using person-first language, NIDA recommends avoiding the term "substance abuse" and its derivatives in favor of "use," "misuse," or "use disorder(s)" where appropriate. Similarly, "abuse potential" may be replaced with "addiction liability." NIDA encourages using the term "medications for opioid use disorder" (MOUD) instead of "medication-assisted treatment" (MAT) or "opioid substitution therapy" (OST) when referring to medications prescribed for the treatment of OUD. The term MOUD appropriately frames these life-saving medications as effective, front line treatments. In contrast, the term MAT implies that medication should have a supplemental or temporary role in treatment. OST reinforces the misconception that MOUD "substitutes" one drug for another instead of supporting recovery. The terminology shift to MOUD aligns with the way other psychiatric medications are understood (e.g., antidepressants, antipsychotics) as critical tools central to a patient's treatment plan. These small but powerful substitutions may help address stigma in patients and study participants, which research shows reduces willingness to seek and accept treatment, among other adverse health outcomes. For more information on preferred language in addiction care, visit NIDAMED: The Small Business Innovation Research (SBIR) program is a phased program. An overall objective of the SBIR program is to increase private sector commercialization of innovations derived from federally supported research and development. The main objective in SBIR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts. In contrast, the SBIR Phase II objective is to continue the R&D efforts to advance the technology toward ultimate commercialization. Beyond the scope of this NOFO, it is anticipated and encouraged that the outcomes of successful SBIR projects will help attract strategic partners or investors to support the ultimate commercialization of the technology as a publicly available product or service. This NOFO invites three types of applications: Phase I. The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and determine the quality of performance of the small business recipient organization before proceeding to Phase II. Fast Track. In an NIH SBIR fast-track both Phase I and Phase II are submitted and reviewed as one application to reduce or eliminate the funding gap between phases. Fast-Track (Phase I/ Phase II) applications should include a clear rationale of the technical and commercial feasibility of the proposed approach and technology in the SUD area; demonstrate a high probability of commercialization; include specific, measurable, achievable, relevant, and timebound milestone deliverables. It is important to clearly state the go / no-go milestone(s) that will determine transition to Phase II and indicate potential Phase III support/interest (non-SBIR) from future commercialization partners. The objective of Phase II (as a part of Fast Track applications) is to continue the R&D efforts initiated in Phase I to advance technologies to potential commercialization. Projects proposed for Phase II are based on the results achieved in Phase I (or equivalent) and aim to demonstrate scientific and technical merit and commercial potential. Therefore, will evaluate whether that investigators have established technical and commercial feasibility in Phase I and whether proposed milestones have been met before deciding on Phase II support. Direct to Phase II. NIH can issue a Direct to Phase II award for a small business that has already demonstrated scientific and technical merit and feasibility but has not received a Phase I award for that project. The NIH SBIR Direct to Phase II is appropriate for Phase II submissions regardless of the funding source for the proof of principle work on which the proposed Phase II research is based. Small businesses eligible to submit Phase II applications for projects supported with a Phase I SBIR award are expected to submit the regular Phase II application as a "Renewal" application based on the awarded Phase I SBIR or Small Business Technology Transfer (STTR) project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. First-time applicants may submit a Phase I, Fast-Track, or Direct-to-Phase II application.
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