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.