Controlled Clinical Trial Shows Kratom Safe and Well Tolerated at Standard Doses

Why it matters

This is the first large-scale controlled human study of kratom dosing, involving 116 volunteers across 47 days. It provides critical scientific evidence on safety parameters that can inform both clinical and regulatory decisions.

The big picture

Kratom research has historically lacked high-quality human studies. As policy debates intensify across states, evidence on actual safety profiles becomes essential. This controlled study examined four escalating single doses (6.65 to 53.2 mg mitragynine) and 15 daily doses, monitoring for adverse effects, abuse potential, and withdrawal symptoms.

Key findings

• No serious adverse events or deaths reported across 116 participants; treatment-emergent adverse events generally increased with dose, most common being dizziness, nausea, and relaxation after single doses; headache and nausea most common with multiple daily doses; no evidence of meaningful abuse potential or withdrawal; participants had no prior kratom use or abstained for ≥12 months

What they say

The researchers concluded that 'Mitragyna speciosa-derived MitraLeaf kratom powder was safe and well tolerated at the dose ranges tested, with no evidence of meaningful abuse potential or withdrawal.'

Bottom line

**In a controlled study of healthy volunteers, kratom leaf powder demonstrated a safety profile without serious adverse events or evidence of addiction potential at standard doses.**