The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. 

The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.  

Nonprofit

• Other Native American tribal organizations
• Nonprofits non-higher education without 501(c)(3)
• Nonprofits non-higher education with 501(c)(3)

Education

• Public and state institutions of higher education
• Private institutions of higher education
• Independent school districts

Business

• For-profit organizations other than small businesses
• Small businesses

Government

• Federally recognized Native American tribal governments
• State governments
• Special district governments
• County governments
• City or township governments
• Public and Indian housing authorities

Miscellaneous

• Unrestricted
• Other