The current study will evaluate the safety, pharmacokinetcs and the effects of MG, especially on subjective outcomes, pain perception, cognitive perfomances and impulsivity.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Veiligheid, effecten, farmacokinetiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
vital signs: body temperature, blood pressure, heart rate, respiration rate,
peripheral capillary Oxygen saturation, hematology, biochemistry and
urinalysis, subjective drug experience, pain perception
Secondary outcome
pharmacokinetics, cognitive performance and impulsivity
Background summary
Kratom has recently become popular as NPS in Western countries. Mitragynine
(MG) is the most abundant alkaloid present in Kratom. It is used also for the
treatment of opioid withdrawal symptoms and of pre-existing mental health
symptoms in non medical settings. MG is a dose dependent agonist of opioid
receptors in the central nervous system (CNS) as well as non-opioid receptors.
Its non-selectivity likely results in the beneficial multimodal effects of
kratom. The adverse effects or the toxicities have been studied mainly in vitro
and in animal models. In humans they have been documented only in case reports
or online surveys, and there are just two controlled studies. Despite the fact
that Kratom became popular and is easily available, the potential risks and
real benefits in humans are insufficiently known. That's why, with the current
study, we intend to elucidate safety, pharmacokinetics and effects of MG,
particularly its abuse liability and its impact on pain perception,
neurocognitive measures and impulsivity in a well-controlled manner.
Study objective
The current study will evaluate the safety, pharmacokinetcs and the effects of
MG, especially on subjective outcomes, pain perception, cognitive perfomances
and impulsivity.
Study design
This intervention (placebo-controlled, single blind, within subjects) study
will be performed in 16 healthy participants. In the first part, an escalating
dosing scheme will be used in 8 participants, with each participant receiving
placebo and 3 single doses of 5, 10 and 20 mg of MG. Participants will be
closely monitored for 7 hours after drug administration. Only when the
administration in the previous participant did not cause serious adverse
effects, administration of the same dose will be repeated in a next
participant. Only in case the lower dose did not cause serious adverse effects
in any of the 16 participants, administration of the subsequent dose will be
started for the participant. Participants will stay under an observation period
of 7 hours after the administration. Then, the experimenter will check whether
it is safe for the participant to be discharged. In case the participant still
shows signs of intoxication, he/she will be kept under observation until these
signs will have disappeared. A wash-out period at least of 5 days between each
dose will be used and subjects will be tested once per week for 4 consecutive
weeks.
In the second part of this study, a new group of healthy volunteers (N=8) will
receive placebo and 40 mg MG on separate test days. The design of this part is
otherwise identical to the first part. An interim evaluation will be performed
after half of the participants have completed the study, in order to evaluate
safety and appropriateness of the dose.
Intervention
0, 5, 10, 20, 40 mg MG
Study burden and risks
During the test day subjects remain 7.5 hours in the department, where their
vital signs will be monitored at regular intervals. Blood and urine samples are
taken at the baseline and at the end of the test day. A small blood sample for
pharmacokinetics will be taken twice after drug intake and at the end of the
test day. A few times the subject must perform pain tolerance test and
cognitive tasks. He also must fill out scales and questionnaires regarding drug
experience, safety and impulsivity.
The subject may experience side effects that are similar or less strong than
those with low dose of Kratom. A medical doctor will be present and can
intervene in time in case of serious side effects.
Universiteissingel 40
Maastricht 6229 ER
NL
Universiteissingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
*Age between 18 and 45 years
*Healthy (the participant is, in the opinion of the investigator, generally
healthy based on assessment of medical history, physical examination, vital
signs, electrocardiogram (ECG), and the results of the haematology, clinical
chemistry, urinalysis, and other laboratory tests (thyroid function test, TSH)
* a resting pulse and heart rate (as measured by the medical doctor) *51 bpm
and *100 bpm. For participants in good physical condition, the lower limit is
*45 bpm.
* a resting systolic blood pressure *91 mmHg and *140 mmHg and a resting
diastolic blood pressure *51 mmHg and *90 mmHg.
*clinical laboratory test values within the reference ranges. Borderline values
may be accepted if they are, in the opinion of the investigator, clinically
insignificant.
*Absence of any major medical, endocrine and neurological condition, as
determined by the medical history, medical examination, electrocardiogram and
laboratory analyses (haematology, clinical chemistry, urinalysis)
*Weight range between normal and overweight:body mass index (BMI:
weight/height2) between 19,5 and 28 kg/m2
*To be proficient in Dutch or English
*Written Informed Consent
Exclusion criteria
*Current or history of medical or psychiatric disorder (determined by the
medical questionnaire and medical examination)
*Any use of medications (except paracetamol if it is necessary)
*History of drug abuse or addiction (determined by the medical questionnaire,
drug questionnaire and medical examination)
*Excessive drinking (> 20 alcoholic consumptions a week)
*Pregnancy or lactation or failure to use contraceptives
*Serious side effects to previous Mitragynine administration
*Simultaneous participation in another clinical trial
*For women: not using reliable contraceptive
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73317.068.20 |
| Other | Not yet available |