Evidence map›Paper›PMID 39724441›Full record

ArticlePsychopharmacology2025

An exploratory study of the safety profile and neurocognitive function after single doses of mitragynine in humans.

Elisabeth Prevete, Eef L Theunissen, Kim P C Kuypers, Riccardo Paci, Johannes T Reckweg, Mauro Cavarra, Stefan W Toennes, Sabrina Ritscher, Giuseppe Bersani, Ornella Corazza and 2 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Psychopharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Evaluating the drug interactions in kratom usage: clinical application.Expert opinion on drug metabolism & toxicology · 2025
    Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Elisabeth PreveteDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Eef L TheunissenDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Kim P C KuypersDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Riccardo PaciDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Johannes T ReckwegDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Mauro CavarraDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Stefan W ToennesInstitute of Legal Medicine, University Hospital, Goethe University, Frankfurt/Main, Germany.
Sabrina RitscherInstitute of Legal Medicine, University Hospital, Goethe University, Frankfurt/Main, Germany.
Giuseppe BersaniDepartment of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, Latina, 04100, Italy.
Ornella CorazzaDepartment of Clinical, Pharmacological and Biological Sciences, College Lane, University of Hertfordshire, Hatfield, AL10 9AB, UK.
Massimo PasquiniDepartment of Human Neurosciences, Sapienza University of Rome, Viale dell'Università 30, Rome, 00185, Italy.
Johannes G RamaekersDepartment of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands. j.ramaekers@maastrichtuniversity.nl.ORCID http://orcid.org/0000-0003-4553-376X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleDespite the growing scientific interest on mitragynine, the primary alkaloid in kratom (Mitragyna Speciosa), there is a lack of clinical trials in humans.

objectivesThis phase 1 study aimed to evaluate mitragynine's safety profile and acute effects on subjective drug experience, neurocognition, and pain tolerance.

methodsA placebo-controlled, single-blind, within-subjects study was conducted in two parts. In part A, eight healthy human volunteers received placebo and three doses of mitragynine (5, 10, and 20 mg) in a sequential dosing scheme, on separate days. In part B, a second group of seven volunteers received placebo and 40 mg of mitragynine. Vital signs, subjective drug experience, neurocognitive function, and pain tolerance were measured at regular intervals for 7 h after administration.

resultsOverall, mitragynine did not affect most of the outcome measures at any dose. Yet, the lowest dose (5 mg) of mitragynine increased subjective ratings of arousal and attention, accuracy in a sustained attention task, and motor inhibition. The highest dose (40 mg) of mitragynine increased subjective ratings of amnesia and produced mild psychopathological symptoms. Mitragynine did not significantly affect vital signs, and only mild, transient side effects were reported.

conclusionThe present study suggests that low doses (5-10 mg) of mitragynine may cause subjective feelings of stimulation and enhance attention, while the highest dose (40 mg) may cause inhibitory feelings of amnesia and distress. Mitragynine doses up to 40 mg were well tolerated in this group.

Indexed as

CognitionSecologanin Tryptamine AlkaloidsAdultArousalAttentionDose-Response Relationship, DrugFemaleHumansMaleMitragynaPain ThresholdSingle-Blind MethodYoung AdultmitragynineSecologanin Tryptamine AlkaloidsAcute effectsKratomMitragyna speciosaMitragynineNeurocognitionPainPlacebo-controlled studySafety

Identifiers

PMID39724441
PMCPMC12084173

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.