# A human abuse potential study of kratom

> **NIH FDA U01** · BAYLOR COLLEGE OF MEDICINE · 2024 · $1,837,093

## Abstract

PROJECT SUMMARY/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.

## Key facts

- **NIH application ID:** 11058299
- **Project number:** 1U01FD008327-01
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** CHRISTOPHER D VERRICO
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $1,837,093
- **Award type:** 1
- **Project period:** 2024-09-20 → 2027-08-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11058299

## Citation

> US National Institutes of Health, RePORTER application 11058299, A human abuse potential study of kratom (1U01FD008327-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11058299. Licensed CC0.

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