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

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Contract Overview

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AI Contract Overview

The Food and Drug Administration is seeking applications for a cooperative agreement to develop, implement, and evaluate a human abuse potential study focusing on botanical Kratom. This initiative is driven by the fact that Kratom alkaloids show activity at receptor sites associated with abuse, such as mu opioid receptors, yet clinical evaluations of its abuse potential remain limited. The selected party must conduct the study in accordance with the Assessment of Abuse Potential of Drugs industry guidance, which includes determining appropriate outcome measures, statistical analyses, and comparators. Additionally, the contractor is responsible for submitting an Investigational New Drug application and obtaining the necessary Institutional Review Board clearance.

General Info

FDA seeks study on Kratom’s abuse potential using strict guidelines and U01 funding with IRB and IND requirements.

Agency

Department Of Health And Human Services → Food And Drug Administration

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

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Timeline

PostedNov 24

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → Food And Drug Administration

Contacts1 person available

OfficeUSA

Organization / Agency

Department Of Health And Human Services → Food And Drug Administration

Office AddressUSA

Contacts

Terrin Brown Grantor

contact@example.gov

+1 (555) 000-0000

Full 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.