This study will look at the differential effects of variations in cannabis chemovars on driving ability and cognition
Conditions
Interventions
Trade Name: Bedrocan
Product Name: Bedrocan
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: DRONABINOL
CAS Number: 1972-08-3
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Occasional cannabis users (>10 lifetime exposures and 3000 km/yr) • Written Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to test whether variations in the CBD content of vaporised cannabis alter the impairing effects of THC on driving ability. To test this, we will compare the effects of three cannabis chemovars (A: High THC / Low CBD (Bedrocan); B: High THC / High CBD (Bedrocan/Bedrolite); C: High CBD / Low THC (Bedrolite) and placebo in 20 occasional cannabis users. The primary outcome measure is standard deviation of lateral position (SDLP; i.e. lane weaving), a measure of driving performance which is highly sensitive to the effects of drugs and alcohol.;Secondary Objective: This study will also seek to test whether variations in the CBD content of vaporised cannabis alter the effects THC on cognitive task performance and subjective drug effects (e.g. stoned, sedated). This study will also look at plasma concentrations of THC, CBD and their metabolites to assess whether CBD modulates THC pharmacokinetics.;Primary end point(s): 1: Driving performance, as assessed by standard deviation of lateral position (SDLP);Timepoint(s) of evaluation of this end point: On-road driving performance will be assessed in each experimental session at 0.75 h and 4 h after drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Additional measures of driving performance, including: a) Time out of lane (TOL) b) Mean speed c) Standard deviation of speed 2) Performance on the Digit Symbol Substitution Task (DSST), Divided Attention Task (DAT); Paced Auditory Serial Addition Task (PASAT) and Tower of London task (TOL) 3) Subjective ratings of drug effects and confidence in driving ability 4) Plasma concentrations of THC, 11-OH-THC, THCCOOH and CBD;Timepoint(s) of evaluation of this end point: 1) On-road driving performance will be assessed in each experimental session at 0.75 h and 4 h after drug administration. 2) Performance on the DSST, DAT and PASAT will be assessed at baseline and at 0.25 h and 3.5 h after drug administration. TOL task performance will be assessed at 2.33 h. 3) Subjective drug effects and confidence in driving ability will be assessed at baseline and at 0.25 h, 0.75 h, 2.33 h, 3.5 h and 5.5 h after drug administration. 4) Plasma samples will be taken as baseline and at 0.1 h, 0.5 h, 2.25 h, 3.5 h and 5.5 h. | — |
Countries
Netherlands
Contacts
Public ContactT. R. Arkell
The Lambert Initiative / Maastricht University
Outcome results
None listed