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Vaporised cannabis, driving and cognitio

Phase 1
Conditions
This study will look at the differential effects of variations in cannabis chemovars on driving ability and cognition
Therapeutic area: Not possible to specify
Registration Number
EUCTR2018-003945-40-NL
Lead Sponsor
Maastricht University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
20
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

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

•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)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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