Grants / Department of Health and Human Services / Food and Drug Administration

RFA-FD-24-025: Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)

Closed Closed March 21, 2024 Opportunity RFA-FD-24-025 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2024.

• Award ceiling$2.0 million
• Total funding$2.0 million
• Expected awards1
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to any type of organization.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses, individuals.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $2.0 million per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

What the grant funds

An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health. FDA has warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at mu opioid receptors, receptor sites known to be associated with abuse. Although Kratom use is prevalent, to date, clinical evaluations of abuse potential have not been performed. This research proposal describes a human abuse potential (HAP) study of botanical Kratom. This HAP study will help researchers, scientists, individuals using or considering the use of kratom, and the broader public health community because it will generate important findings related to the safety profile of kratom. The primary objective(s) of the HAP study are to characterize the abuse potential and subjective effects of botanical Kratom. Importantly, FDA currently has a pilot, dose-finding and safety study of botanical Kratom. The pilot study is expected to provide critical information for conducting the HAP study, including information on the Kratom dose, the botanical supply provider, and content for the Investigational New Drug (IND) application (e.g., safety information and chemistry manufacturing and controls (CMC) data). Interested parties are expected to be able to fulfill all the requirements of the IND submission. The study should adhere to the design principles outlined in the guidance for industry: "Assessment of Abuse Potential of Drugs." As described in the guidance, the study should be conducted in a human pharmacology laboratory and can be performed in either an inpatient or outpatient setting. On-site safety measures should be described in addition to subject discharge criteria. The HAP study should be performed in nondependent subjects with a history of recreational drug use, including opioids and botanical kratom. Applicants are expected to provide a statistical analysis plan including a power analysis to justify their proposed sample size. Typically, HAP studies consist of a screening phase, qualification phase, treatment phase, and follow-up visit. During the qualification phase, subjects are administered placebo and a dose of the positive control and evaluated using a bipolar drug liking visual analog scale (VAS) ranging from 0-100.

Category: Agriculture, Consumer Protection, Food and Nutrition.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

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