- Natural product: Kratom (Mitragyna speciosa)
- Associated study: Clinical Assessment of the Drug Interaction Potential of the Psychotropic Natural Product Kratom
In Vivo Interaction Study
kratom tea - midazolam interaction clinical NPDI study
Increased systemic exposure was detected.
midazolam 708298
- CYP3A4 4306811
Results
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Fixed-sequence
Single dosing
Females
Healthy volunteers
Males
Asian
Black or African American
White
12
Participants were 6 males and 6 adult females. Females were non-pregnant.
0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours
Drug or Natural Product Administration
Oral
cocktail
2.5mg
Single dose
Oral
Tea
2g
Single dose
Described as Yellow Indonesian Micro Powder - study ID K51
19.48±0.81, 3.18±0.13, 0.647±0.035, 5.12±0.26, 5.86±0.26, 0.512±0.010, and <0.124±0.0014 (below the limit of quantification) mg of mitragynine, speciogynine, mitraciliatine, speciociliatine, paynantheine, isopaynantheine, and 7-hydroxymitragynine, respectively, in each g of dried leaf powder.
2021
Characterization study: Tanna, R.S. et al. Clinical pharmacokinetic assessment of kratom (Mitragyna speciosa), a botanical product with opioid-like effects, in healthy adult participants. Pharmaceutics 14, 620 (2022).
Pharmacodynamics (PD) & Adverse Events
Due to the subtherapeutic dose of midazolam, pharmacodynamic changes were not measured.
The kratom tea and probe drugs were well tolerated by all 12 participants. No participants experienced severe adverse events. Five participtants experienced lightheadedness or headache during at least one arm that did not result in study discontinuation.