By MountainSageNaturalHealth.com Editorial Team
Kratom has been studied in people, but the controlled human research is small, recent and narrow. Most of what circulates online comes from other kinds of evidence: surveys of people who already use kratom, case reports from clinics and poison centers, and lab and animal work. Each answers a different question, and none shows that kratom works as a treatment. NIDA and NCCIH both say kratom has not been shown to be safe and effective for any medical use.
This page is about the studies themselves: what kinds exist, what each can and cannot show, and how to line a study up against a product label. It does not cover how to take kratom, amounts, preparation or product comparisons, it promises no benefit, and it reviews no product. For the plant and its alkaloids, see What is kratom? and Kratom Alkaloids. For the reasons people report using it, see Why Do People Use Kratom?
What Does the Kratom Research Actually Cover?
Kratom comes from the leaves of Mitragyna speciosa, a tree in the coffee family. NCCIH notes that in Southeast Asia people have traditionally chewed the leaves or brewed them as a tea to fight fatigue. That history is real, but it is background, not a clinical result.
Modern research falls into four groups:
- Controlled human studies. Volunteers receive kratom or a placebo under observation. These can begin to separate a kratom effect from expectation.
- Surveys. People who use kratom describe their own use and reasons. NIDA cites a national survey estimate of about 1.7 million U.S. users aged 12 and older in 2021, and notes that estimates of regular use vary.
- Case reports and poison-center data. Clinicians and poison centers describe what happened to particular people.
- Lab and animal research. FDA says most research focuses on two alkaloids, mitragynine and 7-hydroxymitragynine (7-OH), and that there are published animal studies with kratom extracts.
Are There Clinical Trials of Kratom?
Yes, a few. FDA’s kratom page, current as of December 2, 2025, said there were few published reports from well-designed studies in which kratom was given to humans. Several controlled reports have appeared since. A PubMed search for kratom limited to randomized controlled trials returned five records when we checked on October 9, 2026. A count like that is only a rough guide (the placebo-controlled study of purified mitragynine described below is not on that list), but it shows how small the pool is.
Here are the studies we reviewed, with what each can and cannot tell you. We relied on abstracts and registry records, not full texts.
- Pain-tolerance pilot, 2020. Vicknasingam and colleagues ran a randomized, placebo-controlled, double-blind pilot in Malaysia with 26 men who were regular kratom users. During a one-day inpatient stay, they received a kratom decoction and a placebo drink matched for taste and appearance, in random order. The outcome was how long each person could keep a hand in ice water. The authors reported longer tolerance after the kratom drink. The limits: a small, all-male group of long-time users, tested after a short break from use, on a lab task rather than real-world pain. One competing explanation, in our editorial reading, is that regular users after a break may simply feel better when they get kratom again.
- Single-dose study of kratom leaf, 2026. Reissig and colleagues (authors from FDA, the University of Florida and Altasciences) ran a double-blind pilot in 40 adults who use several recreational drugs and have opioid experience. Each person received one dose of placebo or a single-sourced kratom leaf product. No deaths or serious adverse events occurred. Sleepiness, vomiting and nausea were the most common side effects, higher doses narrowed the pupils, and the highest dose raised ratings such as “drug liking.” The authors caution that results may not represent other kratom products. An FDA-sponsored single-ascending-dose kratom study is also registered as NCT06072170.
- Daily-dose leaf powder trial, 2026. Huestis and colleagues randomized 116 healthy volunteers (49 to a branded kratom leaf powder, 67 to placebo), with single-dose and 15-day daily-dose phases and a 23-day follow-up. Participants were nonsmoking adults aged 18 to 55 who had never used kratom or had not used it for at least 12 months. No serious adverse events or deaths were reported, and side effects generally rose as doses rose. The authors concluded the powder was well tolerated at the ranges tested, with no evidence of meaningful abuse potential or withdrawal. The limits: one product, healthy people, about two weeks of daily use. It cannot speak to long-term use, heavy use, extracts or people with health conditions. A separate 2026 report in Drug Testing and Analysis describes abuse-related outcomes from a randomized, placebo-controlled study of dried kratom leaf powder in healthy kratom-naive adults.
- Purified mitragynine, 2025. Prevete and colleagues ran an early, small, safety-focused (“phase 1”) study. Healthy volunteers received single doses of mitragynine itself, not leaf, in two groups of 8 and 7 people. It was placebo-controlled but single-blind, meaning not everyone involved was kept unaware of what was given. Most measures were unchanged and side effects were mild and brief, though the highest dose raised ratings of amnesia and mild psychological distress. An isolated compound in 15 volunteers does not describe a kratom capsule, tea or extract.
- How the body handles the alkaloids, 2024. A study in Molecules measured blood levels of mitragynine and 7-OH after single and repeated doses of encapsulated leaf powder (the field calls this pharmacokinetics). It describes where compounds go in the body, not whether anything helps.
- Under way. NIDA says it supports research on kratom compounds for pain and opioid withdrawal, and points readers to ClinicalTrials.gov. Psychiatric Times reported in August 2026 on an NIH-led phase 1 safety trial of a mitragynine formulation in healthy volunteers, registered as NCT07204171.
The pattern across these studies: healthy or recreational-drug-using volunteers, short windows, one product at a time, and outcomes about safety and the body’s response. None of the studies we reviewed tested kratom as a treatment for a condition in people who have that condition.
How Do I Read a Kratom Study?
NCCIH’s Know the Science guide to journal articles is a good general primer. For kratom specifically, ask these questions in order:
- Who took part? Healthy volunteers, regular users and people with a condition are three different groups. A result applies, at most, to people like them.
- What exactly was given? Leaf powder, a brewed decoction and a purified alkaloid are different things. NIDA says effects depend on the formulation, how it is taken, other drugs in the body, medical conditions and prior experience.
- What was measured, and for how long? A lab task or a rating scale over hours is not the same as symptoms over months.
- Was there a comparison group? Placebo and blinding reduce wishful thinking. A survey has neither.
- How big was it? Dozens of people can show a signal but cannot rule out rare problems.
- What do the authors say about their limits, and who paid? Check the funding and disclosure statements. FDA itself says its study results must be read against the many varied kratom products on the market.
A label-and-safety map for matching a study to a product
Once you know what a study tested, use this map to see whether it says anything about the product in front of you:
- Botanical name and plant part. Look for Mitragyna speciosa and the part used, such as leaf. A leaf-powder trial does not describe an extract.
- Named alkaloids. A figure for mitragynine or 7-OH on a label is the maker’s statement. FDA says 7-OH is a minor constituent of natural leaf, under 2% of total alkaloids, but far more potent at opioid receptors than mitragynine, and it has a separate page on 7-OH products. The 2026 FDA-linked pilot used a leaf with trace 7-OH, so it does not describe a concentrated 7-OH product.
- Product form. NIDA lists capsules, powder, brewed tea and liquid extract. Evidence from one form does not carry to another.
- Interaction questions. NIDA says many people who use kratom also use other drugs, that case reports link combinations to severe adverse effects, and that more research on interactions is needed. Trials in healthy volunteers are not built to answer questions about your medicines.
- Limits of outcome claims. A page or label promising pain, mood, sleep or withdrawal results goes beyond what NIDA, NCCIH and FDA say the evidence supports. FDA says it acts against false or misleading claims about unproven kratom benefits.
For the general skills behind this, see How to Read an Herbal Supplement Label for Safety Information and What Third-Party Testing Can and Cannot Tell You About Botanicals.
What Remains Unknown About Kratom?
These are open research questions, not settled findings:
- Long-term effects. NIDA says there is little evidence on how kratom affects someone over time, and that case reports link long-term use of large amounts to liver problems in a small minority of people, unpredictably.
- Effects in people who are not healthy volunteers. That includes older adults, people with medical conditions and people on prescribed medicines.
- Pregnancy. NIDA reports very little research, plus case reports of opioid-like withdrawal in newborns of women who regularly used kratom.
- Dependence and abuse potential. FDA’s page said a well-designed human abuse-potential study had not been done and that it awarded a grant for one in September 2024. The 2026 reports above are early data, not a final answer.
- Whether kratom has any therapeutic use. NIDA says animal studies suggest properties that may warrant further study, and that researchers have not proven kratom safe or effective for any medical purpose.
What the Evidence Cannot Tell Us
- Surveys cannot show cause. They show what people who use kratom say about it, not that kratom produced the result.
- Case reports show a signal, not a rate. NIDA describes a 2019 poison-center analysis that linked 11 U.S. deaths between 2011 and 2017 to kratom exposure, two of them with kratom alone. FDA says deaths usually involved other drugs, and NIDA says nearly all involved other drugs or contaminants, so kratom’s own contribution is unclear.
- Lab and animal findings are not human results. A compound that acts on a receptor in a dish or a rat has not been shown to help or harm a person.
- A short, small trial cannot rule out rare events. In our reading, trials of dozens or a hundred-odd volunteers over days or weeks are not sized to detect problems that NIDA says occur unpredictably in a small minority.
- Results do not transfer cleanly between products. NIDA and FDA report contamination in some kratom products, including Salmonella and heavy metals, and each study above tested one specific material.
- No study here tells you what is right for you. That depends on your health history, medicines and circumstances.
Appropriate Next Step
If kratom is on your mind, use what you have learned to prepare questions for a pharmacist or qualified health professional rather than to reach a conclusion on your own. Useful questions:
- Does anything I take, including over-the-counter products, supplements and alcohol, raise a concern alongside kratom?
- Do my liver, heart, mental health or pregnancy status change the picture?
- Which of the studies I have read apply to someone like me, and which do not?
- What symptoms should prompt me to call, and who should I call?
Our guide to building an herb and medicine list for a safer pharmacist conversation shows how to get ready. For a possible poisoning or bad reaction, the Poison Help line is 1-800-222-1222, and in an emergency call 911. You can report a bad reaction to FDA through its MedWatch program. If kratom use feels hard to control, NIDA lists the SAMHSA National Helpline at 1-800-662-4357.
Sources and Limits
We reviewed the pages below on October 9, 2026. Rules and research change quickly, so check the originals.
- U.S. Food and Drug Administration, FDA and Kratom (content current as of December 2, 2025).
- National Institute on Drug Abuse, Kratom (modified March 11, 2026).
- National Center for Complementary and Integrative Health, Kratom (last updated April 2022, the oldest source here).
- PubMed and ClinicalTrials.gov records for the studies linked above.
For the trials we read abstracts and registry records, not full texts. Statements about surveys, case reports and poison-center data come from how NIDA and FDA describe them; we did not open the underlying papers or the World Health Organization’s kratom review. This article describes the research in general and does not evaluate any product, seller or person’s situation.
This article is general education and is not medical or legal advice. Talk with a pharmacist or qualified health care provider about your own medicines, conditions and circumstances.