Veiligheid, effecten, farmacokinetiek not applicable
Conditions
Interventions
0, 5, 10, 20, 40 mg MG
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs: body temperature, blood pressure, heart rate, respiration rate, peripheral capillary Oxygen saturation, hematology, biochemistry and urinalysis, subjective drug experience, pain perception | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics, cognitive performance and impulsivity | — |
Countries
Netherlands
Outcome results
None listed