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

Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) is offered by Food and Drug Administration. Max award: $2,000,000. This is a forecast; the deadline is not set yet.

Opportunity numberFOR-FD-24-010
AgencyFood and Drug Administration
StatusForecasted
PostedNov 24, 2023
ClosesNot set
Award ceiling$2,000,000
Award floor$2,000,000
Total program fundingNot specified
Expected awards1
Who can applyIndependent school districts, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Others (see text field entitled "Additional Information on Eligibility" for clarification), State governments, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", City or township governments, Public housing authorities/Indian housing authorities, Public and State controlled institutions of higher education, For profit organizations other than small businesses, Private institutions of higher education, Native American tribal governments (Federally recognized), Small businesses, Native American tribal organizations (other than Federally recognized tribal governments), County governments, Special district governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
CategoryAgriculture, Consumer Protection, Food and Nutrition

Summary (excerpt)

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 prevale…

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