The current study will evaluate the safety and pharmacokinetic profile of 4-FA.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Veiligheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
vital signs; ECG, blood pressure, heart rate, saturation, respiratory,
hematology, biochemistry and urinalysis
Secondary outcome
pharmacokinetics, cognitive performance and subjective experience
Background summary
There are lots of new psychoactive substances (NPS), such as 4-fluoroamfetamine
(4-FA) available, which are widely sold under the name 'legal high' or
'research chemicals'. NPS cover a wide range of substances having
pharmacological properties and effects that are similar to those of
conventional drugs. In the early years, four FA was mainly added to other drugs
such as ecstasy pills, and was considered adulterant or pollution. In NL is
4-FA already very popular for years, while the potential risks are not known to
man. Therefore, this current study will look at the safety and pharmacological
profile of 4-FA, in humans.
Study objective
The current study will evaluate the safety and pharmacokinetic profile of 4-FA.
Study design
The study is carried out in a limited number of participants (batch #1 N=6;
batch #2 N=6). These subjects will receive placebo and 4-FA in an ascending
dosage. Subjects will be one by one (on different days), 100 mg of 4 -FA, after
which their vital signs are monitored up to 12 hours after administration.
Saliva, blood,urine and earwax samples will taken at regular inervals. In
addition, cognitive functioning and subjective experience will also be measured
regularly. The next person will only start with the study when no substantial,
drug-related adverse events have occurred in the last person.Side effects are
reported up to 72 hours after administration. An interim analysis will be
carried out at the time of 3, 6, 9 and 12 people have completed this condition.
Intervention
0, 100 mg 4-FA
Study burden and risks
During the test day subjects remain 12.5 hours in the department, where their
vital signs will continuously be monitored. Blood, urine, saliva and earwax
samples are taken at regular intervals, and a few times the subject must
perform cognitive tasks and fill out questionnaires. The subject may experience
side effects that are similar or less strong than the effects of amphetamine
and ecstasy / MDMA. A medical doctor will be present and can intervene in time
in case of serious side effects.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• Previous experience with psychostimulants (<= 1 time / week) and at least one time during the previous year
• Age between 18 and 40 years
• Free from psychotropic medication
• The participant is in good health, in the opinion of the investigator, based on assessments of medical history, physical examinations, vital signs, electrocardiogram, and the results of haematology, clinical chemistry, urinalysis, serology, and other laboratory tests
• 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, serology)
• Normal binocular visual acuity, corrected or uncorrected
• Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2
• Written Informed Consent
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)
• Pregnancy or lactation
• Hypertension (diastolic> 90; systolic> 140)
• Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
• Liver dysfunction
• (Serious) side effects to previous psychostimulant use
• History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*)
• Simultaneous participation in another clinical trial
• For women: not using reliable contraceptive
• 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 |
|---|---|
| EudraCT | EUCTR2016-003127-34-NL |
| CCMO | NL58861.068.16 |
| Other | nog niet beschikbaar |