Safety Profile and Pharmacokinetics of 3-MMC
- Conditions
- Veiligheidnot applicable
- Registration Number
- NL-OMON53217
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
- 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 <=100 bpm. For
participants in good physical condition, the lower limit is >= 45 bpm
- 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
- Normal binocular visual acuity, corrected or uncorrected
- Absence of any major medical, endocrine and neurological condition, as
determined by the medical history, medical examination, electrocardiogram and
laboratory analyses (hematology, clinical chemistry, urinalysis, serology)
- Normal weight, body mass index (weight/height2) between 18,5 and 28 kg/m2
- Ability to provide written Informed Consent and comply to study requirements
- Participants must be willing to refrain from taking illicit psychoactive
substances during the study
- Participants must be willing to drink only alcohol-free liquids and no
coffee, black or green tea, or energy drink after midnight of the evening
before the study session, as well as during the study day
- Participants must be willing not to drive a traffic vehicle or to operate
machines within 24 h after substance administration
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety profile, vital signs (body temperature, blood pressure,<br /><br>heart rate), clinical laboratory safety (hematology, clinical chemistry and<br /><br>urinalysis) and side effects are monitored for 5.5 hours after administration<br /><br>of 3-MMC. Pharmacokinetics will be determined for 5.5 hours after<br /><br>administration: blood, urine, and oral fluid samples, will be taken at regular<br /><br>intervals.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>