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From the Kove Labs Science Team
We're pharmacists and scientists working to make kratom safer through clear, evidence-based education. This article is our interpretation of a recent study — translated into plain language, with context and care. We don’t claim the findings as our own, but we believe every kratom user deserves to understand the data behind what they take.

How Much Kratom Is Safe? Here’s What the First FDA Study Found

Presented by Dr. Chad Reissig (FDA Controlled Substance Staff) • February 2024

Study Summary

This was the first FDA-funded human study to evaluate kratom’s safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) using a single ascending dose (SAD) design. Conducted under an Investigational New Drug (IND) protocol, the study involved well-characterized, GMP-produced kratom capsules (500 mg) sourced from a known botanical supplier.

Key Insights

  • Five dose cohorts tested: 1g, 3g, 8g, 10g, and 12g (n=8 per cohort, 2 received placebo).
  • Participants were non-dependent recreational polydrug users with prior opioid and psychoactive experience.
  • Primary outcomes: safety, tolerability, and basic PK/PD endpoints (e.g., VAS for drug liking, high, take again).
  • No serious adverse events were reported. Mild nausea/vomiting occurred but remained within safety thresholds.
  • Data were blinded at time of presentation, but early indicators suggested kratom was well tolerated under controlled conditions.

Our Take

This foundational study marks a turning point in U.S. kratom research. While the data are early and limited, it sets a precedent for controlled clinical trials with standardized kratom products. Importantly, it reinforces Kove Labs’ focus on clear dosing, transparency, and product purity.

Scoring Snapshot

Study Type:
Pilot SAD Human Study
Sample Size:
~40 participants (blinded)
Strength of Evidence:
Preliminary
Risk of Bias:
Low (controlled protocol)

Why It Matters

This study demonstrates that kratom can be tested in a rigorous, clinical setting — and highlights the importance of regulated, standardized formulations in ensuring user safety and trust.
Medically Reviewed by J. Lott, PharmD, MPP
Dr. Lott is a pharmacist and public policy expert working at the intersection of harm reduction and clinical research. Read full bio →

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