Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
FDA is offering a cooperative agreement to support the design, implementation, and evaluation of a human abuse potential (HAP) study for botanical kratom (Mitragyna speciosa). The work must follow FDA guidance for abuse-potential assessment, including choosing appropriate comparators and outcomes and conducting required statistical analyses, with clinical regulatory steps such as IND submissio…
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