# Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)

Source: https://welltoldgrants.com/grants/rfa-fd-24-025-cooperative-agreement-to-support-a-human-abuse-potential/  
Official notice: https://www.grants.gov/search-results-detail/351644

> Food and Drug Administration offered grants of up to $2.0 million to any type of organization. It expected to make one award worth $2.0 million in total. Applications closed on March 21, 2024.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-24-025 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 21, 2024 |
| Award ceiling | $2.0 million |
| Award floor | not stated |
| Expected awards | 1 |
| Total funding | $2.0 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

## 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.

## Questions people ask

### Is RFA-FD-24-025 still open?

No. It closed on March 21, 2024. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)?

Food and Drug Administration accepted applications from any type of organization.

### What is the deadline for Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)?

Closed March 21, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $2.0 million each. About $2.0 million in total for one award.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.