In this study, we want to know more about the acute effects of cannabis on neurotransmitter systems. For this, we compare the effects of cannabis with the effects of placebo in 50 healthy participants, both occasional and chronic users. During and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
veranderingen in de hersenen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurotransmission of glutamate, GABA and dopamine, farmacokinetics of THC and
subjective drug experiences.
Secondary outcome
n.a.
Background summary
Chronic use of cannabis can cause changes in the brain, leading to drug
dependence. These brain changes are mainly related to neurotransmitter systems.
At this time, however, little is known about the changes in the brain that
occur during drug use.
Study objective
In this study, we want to know more about the acute effects of cannabis on
neurotransmitter systems. For this, we compare the effects of cannabis with the
effects of placebo in 50 healthy participants, both occasional and chronic
users. During and after the administration of cannabis and placebo, the acute
changes in brain chemicals will be mapped by means of brain scans.
Study design
Double-blind, placebo-controlled 2-way crossover design in which healthy
cannabis users (30 occasional and 20 chronic users) will participate. On two
separate test days placebo and cannabis will be administered in the scanner,
and their brain activity will be recorded. In addition, blood samples will be
taken at regular intervals, cognitive performance will be measured and subjects
will fill in questionnaires about their drug use and subjective experiences.
Intervention
Placebo and bedrobinol (300 microgram/kg bodyweight)
Study burden and risks
The subjects will inhale placebo and Bedrobinol , in a cross-over study. The
subjects will be in a scanner for maximally 1.5 hours. Blood samples are taken
at regular intervals throughout the test day.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
*Occasional users:Used cannabis between 1 times a month and 1 times a week
during the previous year
*Chronic users: Used cannabis at least 3times/week during the previous year
*Age between 18 and 40 years
*Free from psychotropic medication
*Good physical health as determined by medical examination and laboratory
analysis
*Absence of any major medical, endocrine and neurological condition
*Normal weight, body mass index between 18 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)
*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,*)
*For women: no use of a reliable contraceptive
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002977-12-NL |
| CCMO | NL49896.068.14 |