Key Dates

Related Announcements

PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-183- Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

There is an urgent need for remotely delivered Substance Use Disorder (SUD) treatments to reduce patient burden and for methods to conduct clinical trials remotely. The purpose of this NOSI is to stimulate research to evaluate the safety and efficacy of telemedicine or remotely provided treatments for SUD, and to develop tools for remote collection of data in clinical trials of treatments for SUD.

Background

Most mainstream treatments for SUD currently rely on in-person clinical visits as an essential setting for treatment delivery and outcomes monitoring. The advent of the COVID-19 pandemic has substantially disrupted in-person treatment delivery, demonstrating the limitations of relying on in-person approaches. Further, even during normal circumstances, in-person treatment delivery results in additional travel-related demands and schedule conflicts (e.g., work, childcare) that can be burdensome to patients. These issues may be addressed via remote treatment delivery and patient outcomes monitoring as exemplified by telemedicine. Few studies have demonstrated that remote delivery of SUD treatment is feasible, safe, and efficacious. These remote delivery methods are generally still in the early stages of development, and existing studies generally lack the scope required to inform dissemination into clinical practice. Therefore, there is a need to develop new remotely-delivered SUD treatments and expand the dissemination of those already evaluated.

Similarly, clinical trials of SUD interventions generally require frequent in-person contact to monitor tolerability, adherence, and efficacy outcomes. The COVID-19 pandemic halted most SUD clinical research, which is evidence that methods for conducting clinical trials remotely are needed to overcome these challenges when participants cannot attend in-person clinic visits. Thus, there is an urgent need of research to develop tools to reduce the frequency of in-person visits in SUD clinical trials.

We expect this NOSI to accelerate the development of 1) remotely-delivered SUD treatment interventions, and 2) remote methods for collecting outcome measures evaluating the safety or efficacy of SUD treatments. These advances will facilitate the delivery of effective treatments to those in need and permit the execution of clinical trials when physical access to clinical research sites is limited. Ultimately, both these advances will lead to improved treatment options for individuals with SUD.

Research Objectives

NIDA encourages the submission of applications that will rapidly improve the ability to: 1) offer remotely-delivered SUD treatments to patients, including efforts to bring access to difficult to reach populations, and 2) conduct clinical trials of novel treatments using remote patient safety and clinical outcomes monitoring to reduce the need for in-person clinical visits.

This NOSI encourages research among subgroups that have been disproportionately impacted by COVID-19 or have difficulty accessing SUD treatment/research programs, including racial/ethnic minorities, socioeconomically disadvantaged individuals, and rural populations. This NOSI will also prioritize applications that have an impact beyond the circumstances created by the COVID-19 pandemic, for example, applications that address more long-standing barriers to SUD treatments or tackle issues with predominately in-person clinical trials research.

Potential applicants seeking to develop technologies for remote monitoring or treatment delivery should have performed sufficient due diligence to ensure that the proposed technologies address an unmet need or substantially enhance existing capabilities.

Areas of interest include, but are not limited to:

• Development and evaluation of new or existing remote-delivery of treatments for SUD.
• Development and evaluation of new or existing remote-delivery interventions for SUD among patients with or at risk of limitations of mobility, such as:
  • Pregnant or recently postpartum women
  • Older adults
  • Low SES populations
  • Racial/Ethnic minority, or health disparity populations
  • Rural populations
  • Individuals living in Native-American nations
  • Comorbid medical or mental health conditions

• Development and evaluation of new or existing tools and methods for remote monitoring of SUD treatment recruitment, adherence, tolerability, and outcome measures.

• Development and evaluation of research designs that may enhance the implementation of clinical trials that can be conducted remotely, in full or partially, and reduce the number and frequency of in-person clinical visits. These may include recruitment from a larger geographical area, or of patients who live in more rural areas, have disabilities, or have other specific barriers/challenges regarding attending in-person clinical visits (e.g., work during clinic hours, lack childcare, etc.).

- Application and Submission Information

This notice applies to due dates on or after October 5, 2020 and subsequent receipt dates through January 8, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice:

• PA-20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-183- Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-195: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-194: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DA-20-058 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Inquiries

Scientific/Research Contact(s)

Evan S. Hermann, PhD
National Institute on Drug Abuse (NIDA)
Email: evan.herrmann@nih.gov