Fentanyl and its Analogs: Effects and Consequences for Treatment of Addiction and Overdose (UG3/UH3 Clinical Trial Optional)

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The purpose of this Funding Opportunity Announcement is to support research to understand and respond to new challenges in the treatment of drug addiction and overdose, introduced by the now widespread presence of fentanyl and its analogs (fentanils) in illicit drug supplies. The UG3/UH3 Phased Innovation Awards Cooperative Agreement involves 2 phases. The UG3 is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this FOA must address both UG3 and UH3 phases. Applications may focus on the treatment of opioid and polydrug use disorders where fentanils are a major contributor to the problem. The research may include preclinical, clinical, epidemiological or post-mortem studies, but should have high impact and quickly yield the necessary information to understand and effectively respond to the impacts of fentanils in illicit drug supplies. Studies might also aim to develop new or repurposed medications or therapeutic devices or aim to revise therapeutic standards of care. Research dependent on development and implementation of toxicological assessment techniques required to identify and quantitate fentanils and their metabolites, and other opioids or abused substances in clinical and post mortem toxicological samples may also be appropriate if the aims are to understand the public health consequences and treatment of disorders associated with the knowing or unknowing consumption of fentanils. Research to develop new therapeutic medications, indications or devices should be designed to significantly advance the program towards FDA approval for the treatment of fentanil-related Substance Use Disorders or overdose.

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