SABER Welcomes NIH’s First Human Clinical Trial of Mitragynine for Opioid Use Disorder

The Scientific Association for Botanical Education and Research (SABER) today applauded the National Institutes of Health (NIH) for advancing the first randomized, placebo-controlled Phase I clinical trial evaluating mitragynine, the primary alkaloid found in the natural botanical kratom, as a potential treatment for opioid use disorder (OUD).

The study, sponsored by the National Institute on Drug Abuse (NIDA), will evaluate the safety, tolerability, and pharmacokinetics of a purified mitragynine formulation known as MG001 in healthy adult volunteers. The randomized, double-blind, placebo-controlled trial represents the first human study conducted under an FDA-regulated drug development program for mitragynine.

"This is an important moment for kratom research," said Thomas Brendler, PhD, Chair of SABER's Scientific Steering Committee. "For years, there has been considerable discussion about mitragynine's potential benefits and risks, but limited controlled human data. NIH's decision to move this compound into clinical testing reflects the growing recognition that these questions deserve rigorous scientific investigation."

The study will evaluate escalating doses of mitragynine while monitoring a range of safety measures, including cardiovascular, respiratory, and pharmacokinetic outcomes. Researchers will examine how the compound is absorbed, distributed, metabolized, and eliminated in humans while collecting critical safety information needed for future studies.

According to NIH, the research is intended to support the development of mitragynine as a potential treatment for opioid use disorder. While the current study is not designed to evaluate efficacy, it represents an important first step toward understanding whether mitragynine can be safely administered under controlled clinical conditions.

"The significance of this study extends beyond the trial itself," said Dr. Mary Hardy, MD, another member of SABER’s Scientific Steering Committee. "Federal agencies are investing in research to understand the components of botanicals rather than relying on assumptions. That's exactly what many scientists, clinicians, and public health advocates have been calling for."

Hardy noted that the study focuses on purified mitragynine rather than the synthetic or semi-synthetic drugs that have emerged in recent years.

"As policymakers consider how to approach kratom and related products, it is important to recognize that not all products are the same," she said. "Research can help clarify those differences and support more informed public health decisions."

SABER views the launch of the trial as part of a broader shift toward studying botanical compounds through the same scientific framework used for other promising therapeutic candidates and commends NIH, NIDA, FDA, and the research team for advancing this work and looks forward to the publication of the study findings.

About Scientific Association for Botanical Education and Research (SABER)

The Scientific Association for Botanical Education and Research (SABER) is a nonprofit organization dedicated to the evidence-based study, science-forward regulation, and safe access to botanical compounds. Led by a Scientific Steering Committee of medical professionals and researchers, SABER utilizes research partnerships, policy advocacy, and public education to ensure that natural products are studied responsibly and regulated appropriately. To learn more, visit www.saberscience.org.

Media Contact

Paloma Lehfeldt
info@saberscience.org