Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed

The Food and Drug Administration is seeking proposals through a cooperative agreement to support research initiatives in anesthesia, addiction medicine, and pain medicine, with a focus on advancing evidence-based practices for prescribing analgesics, anesthetics, and medications for substance use disorders. Key research priorities include defining clinical trial endpoints and functional measurements for chronic pain patients, developing outcome measures for stimulant use disorder trials, improving the assessment of opioid clinical trials that use active controls alongside placebo, evaluating neurodevelopmental impacts on pediatric patients exposed to anesthesia and opioids, and conducting a living systematic review of pre-clinical studies on anesthetic neurotoxicity. Applicants must design comprehensive, scientifically rigorous plans that translate research findings into actionable clinical guidance and promote appropriate medication use. Multiple awards may be issued under this U01 mechanism, which allows for clinical trials, and applications are expected to align with public health goals related to opioid safety, addiction treatment efficacy, and pediatric neuroprotection. The opportunity is open to qualified applicants through the Department of Health and Human Services, with inquiries directed to Terrin Brown at the FDA. There is no set-aside designation or NAICS code specified, and the solicitation was posted on August 14, 2024, with no fixed deadline indicated in the provided data. Proposals should emphasize innovation, methodology rigor, and the potential for broad dissemination and implementation of research outcomes across clinical and regulatory settings.