To obtain pharmacokinetic data to apply drugs screening in saliva for the addiction setting.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
drugsverslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the detection time (time until cutoff), mean concentration (Cmax),
the time on Cmax (Tmax), the halflife (t1/2) of drugs in oral fluid after using
the drugs.
Secondary outcome
Not relevant.
Background summary
Testing of drugs of abuse is used in addiction threatment settings, in
toxicological research, in justice settings and in workplace testing. A
screening in urine is used in most situations. Testing in oral fluid has
advantages compared to urine in simplicity of sample collection. However, the
most pharmacokinetic data (e.g. duration of detection in oral fluid) are
obtained by studies with healthy volunteers who were administered single doses,
while some studies indicate that pharmacokinetics in chronic users is a lot
different compared to these standardised research groups. It is necessary to
obtain more pharmacokinetic data about drugs in oral fluid of chronic drug
users to generate a reliable judgment of an outcome of a drug screening in oral
fluid.
Study objective
To obtain pharmacokinetic data to apply drugs screening in saliva for the
addiction setting.
Study design
Cohort study.
Study burden and risks
The volunteer has to rinse the mouth with water en hold the oral fluid
collection system in the mouth for maximal 10 minutes (average 5 minutes). This
is not irritating and has not a strange taste. In the research period of 3 days
are 9 oral fluid samples and 3 fingerprick blood samples per day needed.
Besides the regular urine screenings in the addiction threatment institution
(1-3 times per week), 1-2 extra urine samples are needed during the research
period. Urinating with supervision is oncomfortable but familiar to the
volunteer. There are no risks for the volunteer while participating in the
study.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 years or older
- Patient competence
- Recent admission in addiction treatment institution
- Threatment for drug addiction (amphetamine, methamphetamine, cocaine, opiates, cannabinoids) with abstinent policy
- Informed consent
Exclusion criteria
- Not willing to or unable to produce oral fluid.
- (Suspicion of) manipulating the oral fluid or urine sample.
- (Suspicion of) no compliance to the abstinent threatment.
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 | NL39149.101.11 |