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

The Food and Drug Administration (FDA) is seeking applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including the selection of an appropriate comparator(s) and outcome measures, statistical analyses, etc. Interested parties will also need to complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance. • The FDA has previously warned consumers about the use of Kratom, which has demonstrated both affinity and activity at receptor sites known to be associated with abuse. • The proposed HAP study should include the selection of an appropriate comparator(s) and outcome measures, statistical analyses, etc. • Interested parties will need to complete the submission of an IND application and obtain IRB clearance. • The FDA will not accept duplicate or highly overlapping applications under review at the same time.