Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Cl
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 affi
| Agency | Food and Drug Administration |
|---|---|
| Status | Forecasted |
| Opportunity number | FOR-FD-24-010 |
| Posted date | 11/24/2023 |
| Award ceiling | 2,000,000 |
| Award floor | 2,000,000 |
| Expected number of awards | 1 |
| Who can apply | 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 |
| Assistance Listing (CFDA) | 93.103 |
| 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 |
| Agency contact | terrin.brown@fda.hhs.gov |
| Official listing | https://www.grants.gov/search-results-detail/351137 |