In this study we will investigate whether there is cross tolerance for the effects of alcohol and cannabis. Therefore we will investigate both the pharmacodynamic and pharmacokinetic effects of a combined administration of cannabis and alcohol.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitieve disfunctie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is to determine the pharmacokinetic and
pharmacodynamic parameters of THC in combination with alcohol as a function of
time. The Divided Attention Task will be the primary cognitive task and THC
concentration in serum will be used as primary pharmacokinetic value.
Secondary outcome
niet van toepassing
Background summary
Cannabis is the most widely used drugs in the Western world. As cannabis is
used this often, and because it is probable that the therapeutic use of
cannabis will increase, it is important to study the effects of cannabis on
different functions even further. Cannabis is often used in combination with
other drugs, such as alcohol, therefore in this study the combination of the
two drugs will be examined.
Study objective
In this study we will investigate whether there is cross tolerance for the
effects of alcohol and cannabis. Therefore we will investigate both the
pharmacodynamic and pharmacokinetic effects of a combined administration of
cannabis and alcohol.
Study design
Randomized, double-blind, placebo controlled, 3-way cross-over design.
- 21 volunteers, age between 18 and 40, will be randomly assigned to a
treatmentorder
- There are 3 test days in this study, on which the subject will be
administered alcohol. After this the alcohol level will be kept constant by
giving small repeated doses of alcohol. 2,5 hours after the first alcohol
administration, the cannabis sigaret will be smoked. In between test days,
there will be a wash out period of at least 7 days.
- Before inclusion, a medical screening will take place. Also a training of the
different tests will take place.
- On each test day different cognitive test will be administered to the
subjects. A first time after administration of alcohol, and two times after
smoking the cannabis sigaret. Furthermore, 11 blood samples and 12 saliva
samples will be taken at different times during each test day.
Intervention
The amount of alcohol that will be administered will be calculated using a
formula. The aim is to reach a blood alcohol concentration of 0,0, 0,5 or 0,8
on the three seperate testdays. the cannabis sigaret will contain 400 µg THC
per kg bodyweight. The lenght of the sigaret en the amount of alcohol will be
determined for each subject individually, based on his/her bodyweight.
Study burden and risks
The total time investment for the subjects will be about 25 hours. First a
medical screening will take place, in which a physical exam will be done,
including a blood (10ml) and urine sample. The subject will come 3 times to the
trial site for the test days. Each testday will last about 7,5 hours. During
each test day, a cognitive testbattery will be repeated three times.
Furthermore 11 blood samples (8ml each) will be taken. In order to minimize the
burden for the subjects, bloodsampling will be done by inserting a canula. Also
12 saliva samples will be taken. Therefore subjects will have to chew on an
absobent cotton for 1 minute.
In the night before each testday, subjects have to have a good nights rest.
Also they are not allowed to use any alcohol or caffeïne 24 hours before each
testday. There are no risks related to this study.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Good health, age between 18 and 40, experience with cannabis (with a minimum of 1 year, and 200 times a year), written informed consent
Exclusion criteria
use of other drugs
Pregnancy or lactation
no experience with alcohol
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 |
|---|---|
| EudraCT | EUCTR27516.068.09-NL |
| CCMO | NL27516.068.09 |