The effects of medicinal cannabis on driving performance, sedation and mood

Phase 2

• Conditions: Driving performance; Sedation; Mood; Cognitive function; Injuries and Accidents - Other injuries and accidents; Mental Health - Studies of normal psychology, cognitive function and behaviour; Public Health - Other public health

• Registration Number: ACTRN12619000932167
• Lead Sponsor: Cannvalate (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Individuals will be screened to ensure they are deemed eligible to participate in the study. Subjects who meet the following eligibility criteria will be enrolled in the trial:
•Aged between 21 and 60 years
•Hold a full drivers licence (no ‘P’ plates)
•Are regular drivers (> 4,000 km/year) with three years of driving experience
•Have experimented with cannabinoids previously (self-disclosure). This includes any cannabis product (marijuana, skunk, ‘weed’).
•No known allergic reaction to cannabis products with previous use
•Ability to speak and read English
•Have no history of past substance abuse or current abuse of illicit drugs
•Have no pre-existing neurological conditions, no previous or current history of severe psychiatric, cardiac, renal, endocrine, gastrointestinal, or bleeding disorders
•Not currently pregnant or lactating
•Not taken any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne).
•Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
•Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:
•Aged under 21 years or over 60 years.
•Does not hold full drivers licence
•Inability to speak or read English
•History of drug or substance abuse or current illicit drug abuse
•History of neurological conditions or previous or current history of severe psychiatric, cardiac, endocrine, renal, gastrointestinal, or bleeding disorders
•Currently pregnant or breastfeeding
•Currently taking medication (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne)
•Severe depression (a cut off of 20 and higher on the Beck Depression Inventory)
•Severe anxiety (a cut off of 16 and higher on the Beck Anxiety Inventory).
•No previous experience with cannabinoids
•Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in standard deviation of the lateral position (SDLP) measured using the Forum 8 driving simulator between CDB/THC and placebo[Approx. 80 minutes post-dose]