NEW KRATOM STUDY FOCUSES ON SAFETY PROFILE OF NATURAL KRATOM LEAVES

The case for kratom has come a long way from early literature reviews and speculation on effects associated with different products. After 18 kratom leaf human clinical trials, a clear picture is starting to emerge. 

A study published in Therapeutic Drug Monitoring is the latest addition to the growing knowledge base surrounding natural kratom leaf, and strengthened the narrative that such products are well tolerated and have “no evidence of meaningful abuse potential or withdrawal.” The study was endorsed by the Global Kratom Coalition (GKC) and utilized 116 volunteers over 47 days to test the “safety and tolerability” of kratom powder administered in a variety of doses and intervals. 

The study was a randomized, double-blind study that featured dose escalation and had a placebo-controlled group that was larger than those who received different doses of natural leaf kratom. Rather than using habitual kratom consumers, the study’s inclusion criteria required volunteers to either be new to kratom or at least individuals who had not taken kratom in the past year. 

Specs of the Study

Participants were male and female, ranging in age from 18 to 55. There were four different doses, ranging from 500 mg of kratom powder to 4000 mg; each dosage group had 12 volunteers, except for the highest dosage level, which had 13. To establish a control, 67 volunteers in the study received placebos. Participants started with a single dose (SD) and were then given the same amount of kratom in multiple doses (MD) over 15 consecutive days. 

Following the kratom usage, participants continued to be monitored over a 23-day period without kratom, and received a total of 31 in-person clinical visits during the 47 days of the study. Participants in the study adhered to safety parameters and underwent a variety of assessments, including comprehensive metabolic panels, liver and kidney tests, monitoring of vital signs, and evaluations focused on blood oxygen levels and heart health. 

Results of those assessments concluded that “all 4 doses had a generally acceptable safety profile” and “generally mild” adverse events, and the study concluded that “no trend was observed in any vital sign assessment or for increases in abnormal values with increasing dose.” 

The report stated: “Overall, there were no consistent trends across all cohorts, or shifts from baseline to any postbaseline visit for clinical chemistry parameters in participants who received active (kratom).”

Furthermore, the most common adverse events in both the SD and MD phases were nausea, dizziness and headache, leading the researchers to conclude that “kratom powder was safe and well tolerated at the dose ranges tested, with no evidence of meaningful abuse potential or withdrawal.” The study identified euphoric mood as a potential abuse-related adverse event, but only one participant reported such a reaction during the SD phase, and no participants reported that reaction during the MD phase. One participant receiving a placebo also reported a euphoric mood.  

Due to the variety of data collected by medical monitors and the reported adverse effects, the study made it clear: “Taken together, the study findings are consistent with those of other studies and evaluations of kratom pharmacology and safety, which suggest that kratom intake at commonly consumed levels poses low acute-safety risks.”

Implications of the Inquiry

In simple terms, the study continued to make the case that advocates and the Food and Drug Administration (FDA) have made in recent years: Natural leaf kratom does not carry the same concerns and risks that have been associated with the plant. Instead of the opioid-like outcomes often associated with kratom products in general, the study showed that natural leaf products do not carry the same risk of serious side effects and death that have been attributed to adulterated products or those with unnaturally elevated alkaloid levels. 

As part of a press release published by the GKC, the executive director of the organization said this study is just the latest piece of data that kratom advocates can use to push for reasonable regulations instead of prohibition due to safety risks. 

“The study’s findings underscore natural kratom leaf’s established safety profile, reinforced by centuries of safe use in communities from Southeast Asia to here in the United States,” said Matthew Lowe. “With scant evidence of abuse liability and a low acute overdose risk, the science shows that natural kratom leaf remains safe and well tolerated when consumed responsibly.”

This most recent study builds off the safety profile established by a dosage study conducted last year by the FDA. In that study, similar adverse effects were reported, none of which were classified as serious. That study also included a larger kratom dosage than the study endorsed by the GKC–the FDA’s dosage study went up to 12 grams at the maximum dosage, as compared to the 4 grams in the most recent study. 

The growing collection of scientific evidence available for natural leaf kratom is why the FDA decided to target ‘enhanced’ products, while making it clear that natural leaf products do not pose the same risk to public health as other products labeled as kratom.