The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of devices to treat Substance Use Disorders (SUDs). The continuing advances in technologies offer unprecedented opportunities to develop neuromodulatory or neurophysiological devices that are safe and effective SUD treatments. The objective is to move devices to their next step in the FDA approval process, with the ultimate goal of generating new, FDA approved device-based treatments for SUDs.
Substance Use Disorders (SUDs) continue to have a substantial adverse impact in the United States, resulting in costs of more than $700 billion annually due to health care expenditures, lost earnings, and expenses associated with crime and accidents. There are effective pharmacological and behavioral treatments, but the long-term success rate is low and not all individuals are responsive. Furthermore, approved treatments are not available for cannabis, methamphetamine and cocaine use disorders. The development of safe and effective therapeutic devices for SUDs represents an opportunity to address the significant public health need for new SUD interventions.
With the approval of neuromodulatory devices for treatment of mental health disorders such as depression and obsessive compulsive disorder, interest has rapidly grown around applying these and related technologies to SUDs. Studies examining the effects of neuromodulation on nicotine, alcohol, cocaine, and other SUDs have reported some therapeutic effects. Further work, however, is needed to strengthen and build upon these results. High priority areas of research include understanding the relationship between changes in brain circuitry and behavioral responses, what SUD behavioral activities are responsive, how long does the altered behavioral response last, how can devices be used together with FDA approved treatments, and are subsequent treatments needed to maintain the behavioral response.
Application budgets are limited to $500,000 direct costs for each year of the UG3 phase, but are not limited for the UH3 phase. However, budgets need to reflect the actual needs of the proposed project
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Filed Under: Funding Opportunities