Purpose of this study is to investigate whether a sample of oral fluid and sweat on the hands may be used to detect traces of cannabis and to test how log after smoking cannabis traces can be detected.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het is een analytisch-chemische studie met samples van vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Criteria for evaluation:
cannabis contents in saliva samples, both samples analysed by the external
laboratory by the conventional methods and those analysed by means of the
Biosens600.
Secondary outcome
cannabis contents in sweat samples, obtained by the Biosens600
Background summary
The equipment being studied is the BIOSENS®600. The device works according to a
unique method that combines immunoassays and 'Surface Acoustic Wave' (SAW)
technology. The results of the tests are available within minutes and may be
done on-site. the device is meant to be used by the police in traffic control
or by customs. Testing by means of the BIOSENS®600 is less burdensome for the
person being tested than current methods for which blood and urine samples are
being used to test for cannabis use.
Study objective
Purpose of this study is to investigate whether a sample of oral fluid and
sweat on the hands may be used to detect traces of cannabis and to test how log
after smoking cannabis traces can be detected.
Study design
Open, non randomized study with maximally 8 subjects that will be asked to
smoke cannabis on one occasioin. There will be 4 volunteers to not smoke (nor
smoking any cannabis and not smoking any tobacco).
Oral and saliva samples will be taken from the volunteers before and at 1, 2,
3, 4, 5, and 6 hours after smoking cannabis. Before and 4 and 6 hours after
smoking cannabis, a sweat sample will be taken of the fingertips from the
volunteers.
Intervention
Mandatory assessments:
- 24 hours prior to study not smoking any cannabis;
- not eating or drinking until 4 uur after smoking cannabis;
- not eating and drinking till 15 minutes before oral sample taking;
- not drinking any alcohol during the entire study day;
- smoking cannabis at the pre-defined time;
- for the controles only: not smoking any cannabis and tobacco during the study
day.
Sampling:
- Before and at 1, 2, 3, 4, 5, and 6 hours after smoking cannabis: oral and
saliva sample
- Before and at 4 and 6 hours aftere smoking cannabis: sweat sample
Study burden and risks
There are no adverse effects expected with taking saliva and sweat samples.
The most important effect of cannabis is the pleasant feeling it is causing
(*high*). Usually, one feels well, relaxed, experience colours more intense,
experience music more intense, the sense of feeling space and time differs,
fantasy is increasing. Sometimes, psychotic symptoms of fear and panic may
arise, concentration and memory might decrease and the heart beats faster. All
these symptoms disappear when the cannabis smoked during this study ceases to
work. The subjects asked to participate to this study are familiar with the use
and effects of cannabis.
Solna Strandväg 3
SE-171 54 Solna
SE
Solna Strandväg 3
SE-171 54 Solna
SE
Listed location countries
Age
Inclusion criteria
1. Male or female, age 18-65 years
2. Provision of signed written informed consent
3. History of cannabis smoking (defined as smoking cannabis at least 5 times in the last year)
4. Have not smoked cannabis the last 24 hours prior to study start
5. Willing to provide oral, saliva, and sweat samples
Exclusion criteria
1. Any subject with damaged oral conditions, who in the investigators opinion should not participate
2. Any subjects who in the investigator*s opinion would be unsuitable for the study
Design
Recruitment
Medical products/devices used
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 | NL37831.056.11 |