Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you run a clinical research center or CRO with Phase I trial experience and regulatory relationships, the FDA will fund your human abuse potential study of kratom.
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What this is
This FDA-funded opportunity supports a human abuse potential study of kratom, a botanical substance, requiring a full clinical trial (U01 mechanism). The cooperative agreement structure suggests FDA collaboration on study design and oversight. Applicants must have capacity to conduct clinical research on human subjects with DEA/FDA regulatory compliance. This is not a technology development grant but rather clinical research infrastructure funding, best suited for academic medical centers, research hospitals, or established contract research organizations (CROs) with existing IRB approval pathways and Phase I/II trial experience.
Who can apply
Eligible applicants likely include academic medical centers, established clinical research organizations, and teaching hospitals with IRB approval, Phase I trial infrastructure, and prior FDA/DEA regulatory experience. Specific eligibility criteria and award range are not stated in the provided text; check the full FOA for details on institution type, size thresholds, and geographic restrictions.
Topics: kratom abuse potential · FDA clinical trial · human subjects research · cooperative agreement · phase I study
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.