To examine and compare the effects of vaporized medicinal grade cannabis containing known concentrations and doses of the cannabinoids THC and CBD on on-road driving performance and cognitive function.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Driving performance will be assessed using the on-road driving test. Outcome
measures will include standard deviation of lateral position (SDLP), speed (MS)
and standard deviation of speed (SDSP).
Secondary outcome
(1) Cognitive performance as assessed using the Divided Attention Task (DAT),
Digit Symbol Substitution Task (DSST), Paced Auditory Serial Addition Task
(PASAT), Tower of London (TOL) task;
(2) Subjective drug effects and confidence in driving ability as measured by a
series of Visual Analog Scales (VAS); Cannabis effects on anxiety as measured
by the State Trait Anxiety Inventory (STAI) and an emotional Stroop task,
(3) Plasma concentrations of THC, 11-OH-THC, THCCOOH and CBD.
Background summary
There is a growing need to better understand the impact of medicinal cannabis
use on driving. Although prior research suggests that cannabis impairs driving
performance in a dose-dependent manner, it is largely with respect to the
effects of *9-tetrahydrocannabinol (THC) in recreational cannabis users. It is
not clear to what extent these results can be generalised to medicinal cannabis
users. A recent pilot study suggests that there may be little difference
between high and low CBD cannabis, despite anecdotal reports to the contrary,
and that the effects of cannabis on driving may depend on the complexity of the
task. This study will seek to validate these findings, primarily by using an
on-road driving paradigm.
Study objective
To examine and compare the effects of vaporized medicinal grade cannabis
containing known concentrations and doses of the cannabinoids THC and CBD on
on-road driving performance and cognitive function.
Study design
Within-subjects, double-blind and placebo-controlled. Occasional cannabis users
(N=24) will attend four test sessions, each one week apart, in which driving
and cognitive function will be assessed following vaporisation of (1) THC/CBD
containing cannabis, (2) THC only cannabis, (3) CBD only cannabis and (4)
placebo cannabis. The order of these conditions will be counterbalanced across
participants.
Intervention
Vaporized Bedrocan, Bedrolite and matched placebo cannabis (equivalent to 13.75
mg THC and CBD).
Study burden and risks
All participants will inhale cannabis and placebo vapor and will complete 2
on-road driving assessments in each session.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
* Occasional cannabis users (>10 lifetime exposures and <2x/week in the last 12 months)
* Age between 20-50
* 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 (weight/height2) between 20 and 28 kg/m2
* In possession of a valid driver license with at least 2 years driving experience (having driven > 3000 km/yr)
* 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 (pregnancy test, if needed)
* Hypertension (diastolic> 90; systolic> 140)
* Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
* Liver dysfunction
* Use of medications that may impact upon driving ability (e.g. mood stabilisers, sedatives)
* Any serious prior adverse response to cannabis
* History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease)
* QT syndrome
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 | NL68411.068.19 |