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

In plain English

Food and Drug Administration (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet.

Awards are up to $2,000,000 each and the agency expects to make 1 award.

Eligibility is listed as unrestricted (open to any type of applicant), subject to any clarification in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

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• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and state-controlled institutions of higher education
• Native American tribal governments (federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than federally recognized tribal governments)
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others (see the eligibility details in the listing)
• Unrestricted (open to any type of entity above, subject to clarification in the listing)

Additional eligibility information (excerpt from the listing):

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 …

Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):

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. …

Read the full forecast on Grants.gov →