The current study will examine the safety and pharmacokinetic profile of JWH-018.
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, respiration,
hematology, biochemistry and urinalysis.
Amendement 5: cognitive functions and subjective experience
Secondary outcome
farmacokinetics, cognitive performance and subjective experience
Background summary
There are many synthetic cannabinoids available, many of which are sold under
the name 'legal high'. These substances with CB1 or CB2 activity, have
cannabis-like effects, but often with a much stronger potency than natural
cannabis. Although synthetic cannabinoids are becoming more popular the
potential risk in humans is unknown. Therefore, the current study will look at
the pharmacological and safety profile of JWH-018, in humans.
Study objective
The current study will examine the safety and pharmacokinetic profile of
JWH-018.
Study design
The study is carried out in a limited number of participants (N = 6). These
subjects will be given placebo and JWH-018 in increasing doses.
Test subjects will be given one by one (on different days), 2mg JWH-018, after
which their vital signs monitored up to 12 hours after administration. At
regular intervals, saliva, blood and urine samples taken. In addition,
cognitive function and subjective experience also measured regularly. The next
person will only start with the study when there are no substantial,
drug-related adverse events have occurred in the previous person. An interim
analysis will be carried out when 3 and 6 persons have completed this condition.
The next part of the study, involving 3 mg JWH-018, will only start when no
substantial effects have been reported with the 2mg dose. Also in this
condition subjects are tested one by one, and the following subject can start
only when the last day of testing was completed without substantial side
effects. Side effects up to 72 hours after administration are reported. An
interim analysis will be carried out when 3 people have completed this
condition.
A new group (amendment 3) of 12 subjects will be given 75µ JWH-018/kg bodyweigh
and placebo. Also in this part, participants are tested one by one (on
different days), and a next person will only start with the study when there
are no substantial, drug-related adverse events have occurred in the previous
person. Side effects up to 72 hours after administration are reported. An
interim analysis will be carried out when 6 persons have completed this
condition.
A third groep (amendement 5) of 24 participants will receive 75 µg/kg JWH-018
bodyweight and placebo. When 15 minutes after administration, the subjective
intoxication scale indicates that the participant does not experience a drug
effect, a booster dose of 50 µg/kg JWH-018 will be administered 30 minutes
after the first treatment. This will be repeated if after another 15 minutes
later there is still nog drug effect experienced. Participants are tested one
by one (on different days), and a next person will only start with the study
when there are no substantial, drug-related adverse events have occurred in the
previous person. Side effects up to 72 hours after administration are
reported.
Intervention
2 and 3 mg JWH-018
amendement 3: 75µ JWH-018/kg bodyweight
amendement 5: 75µ JWH-018/kg bodyweight and 1 or 2 booster doses of 50µ
JWH-018/kg bodyweight if needed (maximal total dose 10mg JWH-018)
Study burden and risks
During the test day, subjects will have to stay at the research unit up to 12.5
hours, in which their vital functions will be monitored. Blood, urine and
saliva samples are taken at regular intervals, and a number of times the
subject will perform cognitive tasks and complete questionnaires.
The subject may experience side effects that are similar or stronger than the
effects of natural cannabis. A medical doctor will be present and can intervene
in time when there are serious side effects.
For part 3 of the study (amdement 4) participants will stay approximately 5
hours at the resarch site, while their bloodpressure, heart rate and side
effects will be monitored. Blood, urine and saliva samples will be taken at
regular intervals and at a number of times the subejct will perform cognitive
tasks and complete subjective questionnaires. A medical doctor will be on
stand-by.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Used cannabis between 2 times a month and 2 times a week during the previous year
* Age between 18 and 40 years
* Free from psychotropic medication
* the subject 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, 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.
* 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 (haematology, clinical chemistry, urinalysis, serology).
* Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2
* Written Informed Consent
Exclusion criteria
* History of drug abuse (other than the use of cannabis) or addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
* Experience with synthetic cannabis
* 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 cannabis use
* History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*)
* Simultaneous participation in another clinical trial
* For women: no use of a reliable contraceptive
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 |
|---|---|
| Other | NTR6141 |
| EudraCT | EUCTR2014-001803-33-NL |
| CCMO | NL52240.068.15 |