A human abuse potential study of kratom
Active Cooperative Agreement Awarded Last action
- Award ID
- U01FD008327
- Recipient
-
Baylor College Of Medicine UEI FXKMA43NTV21
- Awarding agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Obligated
- $5,720,893
Award facts
- Assistance listing
- 93.103 Food and Drug Administration Research
- Completion date 73% complete
- Funding agency
- Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services
- Place of performance
- Houston, TX 77030, USA
Award details come from USAspending.gov.
Description
- Abstract
- The escalating use of kratom, an herbal substance with opioid-like properties, has raised significant public health concerns due to its potential for abuse and dependence. Despite a drastic increase in calls to poison control centers regarding kratom-related incidents, human laboratory studies investigating its abuse potential are lacking. The overall objective of this application is to address this GAP by conducting a comprehensive evaluation of the abuse potential and pharmacokinetic (PK) profile of kratom in humans. The study will employ a rigorous, randomized, double-blind, crossover design involving non-treatment seeking recreational opioid users (N=60). Participants will complete 1 of 6 pre-specified treatment sequences according to a balanced 6 X 6 latin square design; each dosing sequence consists of 6 dosing periods that evaluate the abuse potential of 1 of the 6 study treatments, including kratom at different doses, positive control drugs, and placebo. The primary objective is to determine whether kratom elicits subjective effects distinct from those produced by the controls, utilizing standardized visual analog scales (VAS) to assess "drug liking" and other subjective measures. Additionally, the project seeks to characterize the PK profile of kratom following oral administration, focusing on parameters such as absorption, distribution, metabolism, and elimination kinetics. Blood samples will be collected at specified intervals to analyze kratom and its major metabolites, correlating these findings with subjective and physiological effects over time. The anticipated outcomes of this research include valuable insights into the abuse potential and risks associated with kratom use, informing regulatory decisions regarding its scheduling and labeling. By providing comprehensive PK data on kratom, this research will contribute to a better understanding of its pharmacological profile and aid in safeguarding public health against the potential harms of kratom misuse and abuse.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $1,941,900 | |
| Amendment | $1,941,900 | |
| Original award | $1,837,093 |
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Friends Research Institute, Inc. | $260,517 | |
| University Of Florida | $124,940 |
Quick answers
Who received award U01FD008327?
U01FD008327 was awarded to Baylor College Of Medicine by FDA Office of Acquisition and Grant Services (Food and Drug Administration) on September 16, 2024.
How much is award U01FD008327 worth?
$5,720,893 has been obligated on U01FD008327.
Which agency awarded U01FD008327?
FDA Office of Acquisition and Grant Services (Food and Drug Administration) awarded U01FD008327, with funding from Center for Drug Evaluation and Research (Food and Drug Administration).
On GovTribe
See this award's full record
- Every transaction and subaward
- The recipient's other awards and teaming partners
- Similar grant awards
- Ask GovTribe AI about this award