Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
FDA is seeking cooperative agreement applications to design, conduct, and evaluate a human abuse potential (HAP) clinical study of botanical kratom (Mitragyna speciosa). Applicants must follow FDA guidance for assessing abuse potential, including choosing suitable comparators and outcome measures, and performing the work under an IND with IRB approval. The goal is to generate rigorous human ev…
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