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

    This grant supports clinical trials and research to improve pain management, addiction treatment, anesthesia safety, and drug prescribing practices.

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    Funder: Food and Drug Administration

    Due Dates: Forecasted (Estimated FY25; official due date not yet posted)

    Funding Amounts: Up to $2,000,000 per award; multiple awards anticipated

    Summary: Supports clinical trials and research to advance pain management, addiction treatment, anesthesia safety, and evidence-based drug prescribing.

    Key Information: Clinical trials are allowed; opportunity is currently forecasted, not yet open.


    Description

    This cooperative agreement from the Food and Drug Administration (FDA) aims to support research and clinical trials in the fields of analgesics, anesthetics, and addiction medicine. The program seeks to develop, disseminate, implement, and evaluate research that advances the safe and effective use of drug products for pain management, anesthesia, and substance use disorders.

    Priority research areas include:

    • Development and validation of clinical trial endpoints and functional measures for patients with chronic pain.
    • Outcome measures for clinical trials in stimulant use disorders.
    • Assessment of opioid clinical trials using both active control and placebo.
    • Neurodevelopmental outcome assessment in vulnerable pediatric patients exposed to anesthesia and opioids.
    • Living systematic reviews of pre-clinical studies on anesthetic neurotoxicity.

    Applicants must propose a comprehensive, evidence-based plan that advances appropriate prescribing practices for analgesia, anesthesia, and substance use disorder treatments.


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