Research · 2026-08-21
NIH Clears Mitragynine for First US Clinical Trial in Opioid Use Disorder
Source: Psychiatric Times
Why it matters
This is the first NIH-sponsored human trial of an isolated kratom alkaloid for opioid use disorder, a milestone that could eventually give clinicians a new, FDA-vetted option distinct from unregulated retail kratom products.
The big picture
Mitragynine is kratom's primary active alkaloid and acts as a partial opioid agonist with additional receptor activity that researchers think could ease withdrawal and cravings without the full risk profile of opioids. The trial launches just as the DEA moves to schedule 7-hydroxymitragynine and related synthetic derivatives, a parallel track that regulators say won't affect the leaf-derived trial compound.
Key findings
- FDA accepted an investigational new drug application, clearing an NIH-led phase 1 trial of oral mitragynine (MG001)
- The double-blind, placebo-controlled study will give roughly 32 healthy volunteers a single dose of 25, 50, 75 or 100 mg or placebo
- Participants stay under inpatient observation for 4 days with follow-up on day 7, monitoring vital signs, ECG/QTc, sedation and full pharmacokinetics
- DEA's parallel scheduling of synthetic 7-OH targets concentrated derivatives above a set threshold and does not affect kratom leaf or the MG001 trial
- An earlier, smaller European phase 1 study found low doses (5 mg) boosted alertness while a 40 mg dose increased amnestic effects, consistent with kratom's reported biphasic dose response
What they say
"We have seen the potential of mitragynine in the lab, and now we are finally able to examine its potential in people," said Joni Rutter, PhD, director of the National Center for Advancing Translational Sciences at NIH. "Hopefully, this work will lead to a new treatment option for people with opioid use disorder and support a path to recovery."
Bottom line
**The first NIH-backed human trial of isolated mitragynine could determine whether a purified kratom compound has a future as an approved opioid use disorder treatment.**