Primary objectiveThe primary objective is to determine whether 3-MMC can be safely administered in healthy volunteers in doses up to 100 mg. Participants will be monitored by a medical doctor and vital signs, laboratory safety and side effects will…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Veiligheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable
Background summary
Novel psychoactive substances (NPS) have become increasingly popular and are
easily available on the recreational market, however the potential risks in
humans have not been studied. 3-MMC is a novel psychoactive drug from the
cathinone substitute family. 3-MMC is a monoamine transporter substrate that
potently inhibits norepinephrine uptake and displays pronounced dopaminergic as
well as serotonergic activity. It is closely related in structure to the more
commonly known drug mephedrone (4-MMC). 3-MMC is used recreationally and known
for its psychostimulant effects including empathic feelings, affection,
feelings of awareness and appreciation.
Study objective
Primary objective
The primary objective is to determine whether 3-MMC can be safely administered
in healthy volunteers in doses up to 100 mg. Participants will be monitored by
a medical doctor and vital signs, laboratory safety and side effects will be
measured up until 5.5 hours after administration of the drug.
Secondary objective
Secondary measures include pharmacokinetics, cognitive performance (cognitive
tests), mood and subjective drug experience (questionnaires).
Study design
This exploratory study, will use a double-blind, escalating dose,
placebo-controlled, within-subject design.
Intervention
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 perform an evaluation of all
available safety data before allowing dosing at a higher dose level.
Study burden and risks
Participants will take part in 4 separate test days. Subjects will be quasi
randomly assigned to receive one of the following treatment orders: 0-25-50-100
mg; 25-0-50-100 mg; 25-50-0-100 mg or 25-50-100-0 mg. During each test day,
subjects will be closely monitored for 5.5 hours: they will remain in the
laboratory under medical supervision; ECG, blood pressure, heart rate,
temperature and cardiac arrhythmia will be measured at regular intervals, and
blood samples, urine samples, oral fluid samples, will be taken regularly after
administration. Cognitive performance, mood and subjective drug experience will
be measured at regular intervals.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
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 <=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
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
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 | NL84174.068.23 |