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The U.S. Food and Drug Administration (FDA) has announced a new grant opportunity, identified as FOR-FD-24-010, to support a comprehensive Human Abuse Potential (HAP) study of botanical Kratom. This initiative seeks to understand better the abuse potential of Kratom (Mitragyna speciosa), a plant native to Southeast Asia, which has been a subject of concern due to its opioid-like effects. The grant aims to provide a single award with a budget of $2 million, inviting a wide range of eligible applicants including state, county, city governments, Native American tribal entities, private and public educational institutions, non-profits, and small businesses.
The study will require adherence to the FDA’s guidelines for “Assessment of Abuse Potential of Drugs,” involving detailed clinical evaluations to ascertain Kratom’s interaction with receptors associated with substance abuse, particularly mu opioid receptors. Applicants are expected to propose a study design that includes appropriate comparators, outcome measures, and statistical analyses. Moreover, successful applicants will need to complete an Investigational New Drug (IND) application and obtain clearance from an Institutional Review Board (IRB). This grant opportunity is part of the FDA’s ongoing efforts to protect consumer health by scientifically assessing substances that have potential for abuse. It represents a critical step towards understanding Kratom’s impact and ensuring public safety regarding its use.
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Opportunity ID: 351137
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General Information
| Document Type: | Grants Notice |
| Opportunity Number: | FOR-FD-24-010 |
| Opportunity Title: | Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | |
| Expected Number of Awards: | 1 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 1 |
| Forecasted Date: | Nov 24, 2023 |
| Last Updated Date: | Nov 24, 2023 |
| Estimated Post Date: | |
| Estimated Application Due Date: | |
| Estimated Award Date: | |
| Estimated Project Start Date: | |
| Fiscal Year: | 2024 |
| Archive Date: | |
| Estimated Total Program Funding: | |
| Award Ceiling: | $ 2,000,000 |
| Award Floor: | $ 2,000,000 |
Eligibility
| Eligible Applicants: | State governments County governments City or township governments Native American tribal governments (Federally recognized) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Public and State controlled institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities |
| Additional Information on 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 will not accept: •A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. •A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. •An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications). |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grantor 2403387494
|
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