Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
ID: 351137Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$2M - $2M

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is seeking applications for a Cooperative Agreement to support a human abuse potential (HAP) study of botanical Kratom (Mitragyna speciosa). The objective of this study is to develop, implement, and evaluate the abuse potential of Kratom, which has been associated with both therapeutic and potentially harmful effects, particularly due to its interaction with opioid receptors. This research is crucial as it aims to fill the gap in clinical evaluations regarding Kratom's abuse potential, following previous warnings issued by the FDA regarding its use. Interested applicants can apply for a funding amount of $2 million, with the expectation of one award being granted. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at (240) 402-7610. The opportunity is forecasted for the fiscal year 2024.

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