HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)

Purpose The purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. Specifically, this FOA is focused on applications directed at improving pain measurement and treatment. Background This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative—an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative. More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Innovative scientific solutions to develop alternative treatment options are thus critically needed. Research Objectives A. Scientific/Technical Scope Applications received under this FOA must fall within the scope of the HEAL Initiative, including but not limited to: •Tools and technologies to better understand the biological underpinnings of chronic pain, including new screening tools and models focused on pain and development of pain therapies •Discovery and pre-clinical development of non-addictive pain treatments, including small molecules, biologicals, and devices •Advancing new non-addictive pain treatments through the clinical pipeline •Develop improved pain management strategies for acute and chronic pain conditions, including development of novel pain management technologies and devices, and objective pain measurement B. Clinical Trials Clinical Trials are required through this program announcement. The rationale for a clinical trial must be based on (i) an unmet medical need; (ii) a plausible biological mechanism; and (iii) robust supporting data, e.g., from non-clinical (in vivo and/or in vitro data) studies or preliminary clinical studies that demonstrate there is an adequate scientific foundation to justify the proposed trial. The scientific premise for the trial should be based on preclinical and/or clinical data from rigorously performed studies (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-103.html). If previous research does not meet the rigor criteria outlined to an acceptable degree, applicants should address how the current study design addresses the deficiencies. C. NIH Institute and Center Interests and Guidance National Institute of Neurological Disorders and Stroke (NINDS) The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The National Institute of Neurological Disorders and Stroke (NINDS) is interested in receiving applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NINDS is interested in new screening tools and models focused specifically on pain and development of pain therapies. National Center for Complementary and Integrative Health (NCCIH) The National Center for Complementary and Integrative Health (NCCIH) will support research on development and optimization of technologies relevant to complementary and integrative health approaches and of nonpharmacological therapies for the management of acute or chronic pain conditions. Examples of complementary and integrative health approaches relevant to this FOA include, but are not restricted to, natural products (e.g., herbs, prebiotic, probiotics, and selective medical diets); mind and body practices (e.g., acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies. National Institute on Minority Health and Health Disparities (NIMHD) Areas of interest: The mission of NIMHD is to lead, conduct and support scientific research to improve minority health and reduce health disparities. In the context of this FOA, NIMHD is interested in applications that focus on (but not limited to) the following areas: •Addressing the intersection of chronic pain management and opioid use disorder (OUD): the development of therapeutic strategies and technologies the improve pain management and result in the enhanced continuity of care of patients with chronic pain. •Conducting research/subgroup analyses to identify most effective therapies, technologies, and/or interventions at reducing the need for Opioid pharmacotherapy for specific populations, including the medically underserved and other health disparity populations. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. National Institute of Biomedical Imaging and Bioengineering (NIBIB) The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas can be found at https://www.nibib.nih.gov/research-funding. NIBIB supports research from early stage technology development through first in human demonstrations and early feasibility clinical studies. NOTE: For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports. National Institute of General Medical Sciences (NIGMS) NIGMS accepts applications directed at improving the treatment and management of pain in the peri-operative period, including the development of non-addictive drugs, devices and objectives measures of pain. NIGMS accepts applications on the development of strategies, methods, or new technologies to improve the delivery, monitoring, safety and efficacy of anesthesia. NIGMS also accepts applications relevant to pain management of burn injury. National Institute of Mental Health (NIMH) The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For this FOA, the NIMH is interested in supporting the development of digital health technologies associated with pain and serious mental illness (SMI) or suicide, with the goal to reduce premature SMI mortality and to reduce suicide associated with pain and suffering. Examples of technology priorities within those specific goals include: automated, real time assessments of behavior in naturalistic environments, intervention refinement and delivery, and service delivery. National Institute of Nursing Research (NINR) NINR supports research programs that are developing and refining technologies to improve symptom risk assessment and identify potential interventions, promote health outcomes in diverse and underserved populations, and/or foster health, prevent illness, and improve health-related quality of life across the lifespan. See Section VIII. Other Information for award authorities and regulations.