Assess the effect of 2 doses (10 and 20 mg) dronabinol on driving performance compared to placebo in light and heavy cannabis users. The heavy users are used as a model for chronic use of dronabinol.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief en motorisch functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Standard Deviation of Lateral Position in the driving task.
Secondary outcome
Highway driving and car following on the road and in the simulator.
Field Sobriety Test.
Visual analogue scales of drugeffect.
Addiction Research Center Inventory: Marijuana scale.
THC + metabolites concentration in blood and saliva.
Background summary
Dronabinol is a new medicine and is used for the treatment of chronic pain,
anorexia in AIDS and other wasting diseases and as antiemetic medication in
cancer patients receiving chemotherapy. The active ingredient is synthetic THC
(cannabis) which also occurs naturally in the cannabis sativa plant. It is
known that cannabis reduces driving performance especially in less experienced
users. Since dronabinol is administered orally, it has a different
pharmacokinetic profile and it might also have a different pharmacodynamic
effect. Because road safety might be compromised when people drive under the
influence of a drug that influences driving performance and because this has
not been investigated yet, this study will be relevant to the general society.
Study objective
Assess the effect of 2 doses (10 and 20 mg) dronabinol on driving performance
compared to placebo in light and heavy cannabis users. The heavy users are used
as a model for chronic use of dronabinol.
Study design
The design is double-blind, placebo-controlled, 3-way crossover.
Intervention
All subjects will participate in the following conditions:
1. Dronabinol 10 mg
2. Dronabinol 20 mg
3. Placebo
Study burden and risks
Volunteers visit the University and will be guided by a researcher for physical
examination (45 minutes), a training (2.5 hours) and 3 testsessions (6 hours
per session). Total will be 21.25 hours over 4 weeks.
5 ml of blood will be drawn at the physical examination (1x) and during the
test sessions (4x per session). The participants will perform driving tasks,
the field sobriety tests and fill out questionnaires during the test sessions.
Side effects of dronabinol that might occur at the used dose are dizziness,
confusion, somnolence and feeling high.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Experience with the use of cannabis
Good physical health and free from psychotropic medication
Body Mass Index between 18 and 28
Valid driving license
Able to give written informed consent
Aged between 18 and 40 years
Exclusion criteria
History of drug abuse or addiction
Pregnancy or lactation
Cardiovascular abnormalities
Excessive drinking (>20 drinks/week)
Hypertension
History of or current psychiatric disorder
Susceptibility to simulator sickness
Allergy to sesame oil
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 | EUCTR2009-014402-33-NL |
| CCMO | NL28992.068.09 |