Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
The FDA is funding a clinical trial to study the abuse potential of Kratom, a plant with opioid-like effects, requiring an IND application and IRB clearance.
Funder: Food and Drug Administration
Due Dates: Forecasted (Estimated Application Due Date not yet posted)
Funding Amounts: $2,000,000 (single award; cooperative agreement; U01 Clinical Trial Required)
Summary: Supports a clinical trial to assess the human abuse potential of botanical Kratom, requiring an IND application and IRB clearance.
Key Information: Applicants must be prepared to conduct a human abuse potential study in accordance with FDA guidance and regulatory requirements.
Description
The U.S. Food and Drug Administration (FDA) is seeking applications for a cooperative agreement to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom (Mitragyna speciosa). Kratom is a plant indigenous to Southeast Asia, and its alkaloids have demonstrated activity at receptor sites associated with abuse, such as mu opioid receptors. Despite its widespread use, there is limited clinical evaluation of its abuse potential. The funded project will require a clinical trial (U01 mechanism) and must adhere to FDA guidance on the assessment of abuse potential of drugs, including appropriate comparators, outcome measures, and statistical analyses. Applicants must also complete an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.
