VIVAZEN 28-Day Clinical Evaluation Finds Kratom Extract Well-Tolerated With No Severe Adverse Events

Why it matters

This is among the first industry-sponsored clinical evaluations of kratom extract safety beyond a single dose, providing preliminary data on consecutive daily use tolerability — a key gap in the existing evidence base.

The big picture

Most kratom safety data comes from cross-sectional surveys, animal studies, or case reports of adverse events. Prospective clinical studies evaluating real-world dosing regimens over weeks are rare. While randomized controlled trials of botanical kratom leaf powder have been published, studies of kratom extract formulations over multi-week periods remain limited. This study was funded by VIVAZEN, a kratom manufacturer, and its findings were presented at the University of Florida Fifth Scientific Kratom Symposium in February 2026, though it has not yet been published in a peer-reviewed journal.

Key findings

• The 28-day clinical evaluation assessed the safety and tolerability of VIVAZEN proprietary kratom extract in adult participants
• No severe adverse events were observed during the trial period
• Researchers reported no evidence of dependence or withdrawal over the 28-day consecutive daily use period
• Findings were presented by principal investigator Dr. Paula Brown at the University of Florida Fifth Scientific Kratom Symposium on February 19, 2026
• The study was funded by VIVAZEN, a commercial kratom supplement company, and has not yet appeared in a peer-reviewed journal
• Results are preliminary and should be interpreted in the context of industry sponsorship

What they say

"Policy should be informed by scientific evidence, not fear-based assumptions," said principal investigator Dr. Paula Brown, Director of Applied Research at the BC Institute of Technology and Adjunct Professor at the University of Illinois Chicago. "Our hope is that studies like this will help guide policy decisions that acknowledge the potential benefits of kratom while prioritizing consumer safety."

Bottom line

An industry-funded 28-day study reported no severe adverse events or withdrawal signs in kratom extract users, but the findings require independent peer-reviewed replication before informing clinical or policy decisions.