Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000110785
Ethics application status
Approved
Date submitted
14/01/2022
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Medical Cannabis and Its Effects on Driving
Scientific title
Medical Cannabis and its Effects on Driving: A Prospective, Observational Study in Adults with Chronic Pain
Secondary ID [1] 306213 0
None
Universal Trial Number (UTN)
Trial acronym
MC-AiD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 324925 0
Condition category
Condition code
Public Health 322359 322359 0 0
Other public health
Anaesthesiology 322443 322443 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study will track chronic pain patients over 3 months as they begin treatment with medical cannabis. Participants will attend four (4) lab sessions (pre-treatment & 1, 2 and 3-months post treatment initiation) in which driving and cognitive performance will be assessed. This trial does not involve any medical interventions. These lab sessions will run for 3-4 hours.
Intervention code [1] 322616 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330127 0
Simulator driving performance as measured by standard deviation of lateral position (SDLP).
Timepoint [1] 330127 0
1, 2 and 3 months post treatment initiation
Secondary outcome [1] 404955 0
Simulator driving performance as measured by standard deviation of speed (SDSP)
Timepoint [1] 404955 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [2] 404956 0
Ocular activity (eye closure frequency and saccadic activity) during a simulator driving task
Timepoint [2] 404956 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [3] 404957 0
Neurocognitive performance as assessed using the CANTAB test battery
Timepoint [3] 404957 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [4] 404958 0
Pain score as assessed using the Brief Pain Inventory
Timepoint [4] 404958 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [5] 404959 0
Quality of life as assessed using the 36-Item Short Form Survey (SF-36)
Timepoint [5] 404959 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [6] 404960 0
Score on the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [6] 404960 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [7] 404961 0
Concomitant medication usage
Timepoint [7] 404961 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [8] 404962 0
Subjective drug effects (e.g. 'stoned) & perceived driving ability
Timepoint [8] 404962 0
0, 1, 2 and 3 months post treatment initiation
Secondary outcome [9] 404963 0
Oral fluid cannabinoid pharmacokinetics
Timepoint [9] 404963 0
0, 1, 2 and 3 months post treatment initiation

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participants will be 80 men and women aged 21 years and over. A-priori evaluation of study size indicated that a minimum sample size of 79 is required to detect a meaningful difference in driving performance as measured by SDLP (partial etq squared = 0.26) at 95% power using a two-tailed, repeated measured ANOVA. This effect size is based on the main effect of dronabinol (synthetic medical THC) on real-world driving performance as reported by Veltstra et al. Limited clinical studies have utilised similar designs, albeit typically with smaller samples. In the event of dropouts, we will continue to enrol participants until n=80 participants have completed the study.

The primary outcome will be the SDLP during the second driving test. Data will be analysed using linear mixed models (SPSS MIXED procedure) with time (V1, V2, V3 and V4) as the fixed factor, treatment type (THC-dominant/balanced THC/CBD/CBD-dominant) and dose (mg THC) as random factors, and baseline SDLP as a covariate. Where a main effect of time is observed, planned contrasts will compare SDLP at V2 to SDLP at V1, SDLP at V3 to SDLP to V1 and SDLP at V4 to V1. The same analysis approach will be used for all other time-series outcome measures. Cannabinoid concentrations in oral fluid will be reported descriptively and pharmacokinetic parameters will be calculated (e.g., area under the curve (AUC), time to max concentration (Tmax).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310562 0
Government body
Name [1] 310562 0
Department of Health and Human Services
Country [1] 310562 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Po Box 218 (Mailbox H68)
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 311736 0
None
Name [1] 311736 0
Address [1] 311736 0
Country [1] 311736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310170 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 310170 0
Research Ethics, Integrity and Biosafety Office
Swinburne Research (H68)
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 310170 0
Australia
Date submitted for ethics approval [1] 310170 0
Approval date [1] 310170 0
05/11/2021
Ethics approval number [1] 310170 0

Summary
Brief summary
The aim of this study is to determine whether treatment with prescribed medicinal cannabis (containing delta 9-THC) for long-term symptom control impacts driving and cognitive/psychomotor performance. This will be assessed after 4, 8 and 12 weeks of treatment and examined relative to pre-treatment performance in a group of chronic non-cancer pain patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116738 0
Prof Luke Downey
Address 116738 0
Swinburne University of Technology
Po Box 218 (Mailbox H68)
Hawthorn, VIC 3122
Country 116738 0
Australia
Phone 116738 0
+613 9214 5781
Fax 116738 0
Email 116738 0
ldowney@swin.edu.au
Contact person for public queries
Name 116739 0
Prof Luke Downey
Address 116739 0
Swinburne University of Technology
Po Box 218 (Mailbox H68)
Hawthorn, VIC 3122
Country 116739 0
Australia
Phone 116739 0
+613 9214 5781
Fax 116739 0
Email 116739 0
ldowney@swin.edu.au
Contact person for scientific queries
Name 116740 0
Prof Luke Downey
Address 116740 0
Swinburne University of Technology
Po Box 218 (Mailbox H68)
Hawthorn, VIC 3122
Country 116740 0
Australia
Phone 116740 0
+613 9214 5781
Fax 116740 0
Email 116740 0
ldowney@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unavailable due to collection of sensitive health information.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14662Clinical study report    Available at the end of the study by contacting th... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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