Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)

The U.S. Food and Drug Administration is seeking proposals to conduct a human abuse potential study on botanical Kratom, a plant native to Southeast Asia whose alkaloids interact with mu opioid receptors and have raised concerns regarding misuse. This initiative is part of a broader effort to systematically evaluate Kratom’s abuse liability, as current clinical data remains insufficient despite its widespread use. The study must be designed and executed in strict alignment with the FDA’s Guidance for Industry on the Assessment of Abuse Potential of Drugs, including appropriate selection of comparator substances, well-defined outcome measures, and rigorous statistical methodologies. Applicants are required to submit an Investigational New Drug application and secure Institutional Review Board approval prior to initiating the study. The project will be funded through a U01 Cooperative Agreement, which supports clinical trials and demands a high level of scientific collaboration and accountability. The FDA will oversee the study to ensure regulatory compliance and generate reliable data to inform public health policy and regulatory decisions regarding Kratom. Interested parties should direct inquiries to the designated point of contact, Terrin Brown, at the provided email and phone number.