Medical Cannabis and Its Effects on Driving

Not Applicable

• Conditions: Chronic Pain; Public Health - Other public health; Anaesthesiology - Pain management

• Registration Number: ACTRN12622000110785
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Male/female aged 21 years and over and diagnosed with chronic non-cancer pain
•Current and valid prescription for a THC-containing medicinal cannabis product
•No non-medical cannabis use in the 3-months prior to study enrolment
•Able to attend 4 sessions over a minimum 12-week period

Exclusion Criteria

•Patient is unable to provide written informed consent
•Patient is pregnant or lactating
•Patient has been previously enrolled in the study
•Patient is unable to abstain for illicit drug use for 7 days prior to testing
•Patient reports any non-medical (i.e., recreational) cannabis use in the past 3 months

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Simulator driving performance as measured by standard deviation of lateral position (SDLP).[1, 2 and 3 months post treatment initiation]

Secondary Outcome Measures

Name	Time	Method
Simulator driving performance as measured by standard deviation of speed (SDSP)[0, 1, 2 and 3 months post treatment initiation ];Ocular activity (eye closure frequency and saccadic activity) during a simulator driving task[0, 1, 2 and 3 months post treatment initiation ];Neurocognitive performance as assessed using the CANTAB test battery [0, 1, 2 and 3 months post treatment initiation ];Pain score as assessed using the Brief Pain Inventory [0, 1, 2 and 3 months post treatment initiation ];Quality of life as assessed using the 36-Item Short Form Survey (SF-36)[0, 1, 2 and 3 months post treatment initiation ];Score on the Depression Anxiety and Stress Scale (DASS-21)[0, 1, 2 and 3 months post treatment initiation ];Concomitant medication usage[0, 1, 2 and 3 months post treatment initiation ];Subjective drug effects (e.g. 'stoned) & perceived driving ability[0, 1, 2 and 3 months post treatment initiation ];Oral fluid cannabinoid pharmacokinetics [0, 1, 2 and 3 months post treatment initiation ]