FDA U01 Cooperative Agreement: Human Abuse Potential Clinical Trial of Botanical Kratom
The FDA is soliciting applications for a U01 cooperative agreement to design, conduct, and evaluate a human abuse potential (HAP) clinical trial of botanical kratom. Applicants must follow FDA guidance on assessment of abuse potential, select appropriate comparators and outcomes, submit an IND, and obtain IRB approval; a clinical trial is required to assess kratom’s potential for abuse given i…
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 hav…
Funding Source
Awards & funding
Eligibility
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the FDA…
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