Veiligheid not applicable
Conditions
Interventions
Subjects will receive placebo and single doses of 25 mg, 50 mg and 100 mg 3-MMC
on separate days, following an escalating dose scheme. In the first 6
participants, the Study Safety Group (SSG) will
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age between 18 and 40 years - Previous experience with psychostimulants, i.e., minimum 1 time in the last 12 months - Free from medication and dietary supplements - The participant is, in the opinion of the investigator, generally healthy based on the assessment of medical and psychiatric history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests - Resting pulse and heart rate (as read on the ECG) >= 51 bpm and = 45 bpm - Resting systolic blood pressure >=91 mmHg and =51 mmHg and
Exclusion criteria
Exclusion criteria: - History of drug abuse or addiction (determined by the medical questionnaire, drug questionnaire and medical examination) - Excessive drinking (> 20 alcoholic consumptions a week) - Tobacco smoking (>20 per day) - Current pregnancy or lactation, or pregnancy planned during study participation. Women of childbearing potential will be asked to use a proven birth control method during study participation - Hypertension (diastolic > 90; systolic > 140) - Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination) - Liver dysfunction - (Serious) side effects of previous psychostimulant use - History of cardiac dysfunctions (including arrhythmia, ischemic heart disease) - Simultaneous participation in another clinical trial - Active blood donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety profile, vital signs (body temperature, blood pressure, heart rate), clinical laboratory safety (hematology, clinical chemistry and urinalysis) and side effects are monitored for 5.5 hours after administration of 3-MMC. Pharmacokinetics will be determined for 5.5 hours after administration: blood, urine, and oral fluid samples, will be taken at regular intervals. | — |
Countries
Netherlands
Outcome results
None listed