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Trial registered on ANZCTR


Registration number
ACTRN12620000543987
Ethics application status
Approved
Date submitted
1/04/2020
Date registered
4/05/2020
Date last updated
4/05/2020
Date data sharing statement initially provided
4/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Experiences of patients receiving medicinal cannabis: effects of different doses and formulations on symptoms and side effects.
Scientific title
Dosage patterns and efficacy of medicinal cannabis treatments in patients receiving medicinal cannabis for any condition
Secondary ID [1] 300916 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 316877 0
Pain 316878 0
Sleep quality 316881 0
Cancer 316882 0
Epilepsy 316883 0
Multiple sclerosis 316884 0
Condition category
Condition code
Mental Health 315054 315054 0 0
Anxiety
Mental Health 315055 315055 0 0
Depression
Cancer 315056 315056 0 0
Any cancer
Musculoskeletal 315057 315057 0 0
Other muscular and skeletal disorders
Neurological 315058 315058 0 0
Multiple sclerosis
Neurological 315059 315059 0 0
Epilepsy
Neurological 315060 315060 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Participants will be patients who have been prescribed medicinal cannabis under the Special Access Scheme B via Cannvalate and their medical practitioner. There are various types of medicinal cannabis available in Australia through this scheme and none will be excluded. The dose, mode and duration of treatment will vary across participants depending on what they have been prescribed. Participants will be asked to provide this information as part of the survey (if they choose to participate in that component of the study) and these data will also be collected from medical records (if participants consent to this).
Duration of observation will be over 12 months for the survey component of the study: Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion. For the database/medical records part of the study follow up will be for 5 years or until the participant ceases using medicinal cannabis, whichever is sooner. Note that participants may take part in the survey without consenting to medical records access and vice versa, or can consent to both parts of the study.
Intervention code [1] 317234 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323366 0
Symptom severity measured using the question: Do you experience more or less severe symptoms for your condition now compared to before you started treatment with medicinal cannabis? (much more severe now/ more severe now/ same / less now/ much less
now)
Timepoint [1] 323366 0
Upon first completion of the survey
Secondary outcome [1] 381661 0
Depression measured using the Beck Depression Inventory
Timepoint [1] 381661 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [2] 381662 0
Anxiety measured using the Beck Anxiety Inventory (BAI)
Timepoint [2] 381662 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [3] 381663 0
Sleep quality measured using the Leeds Sleep Evaluation Questionnaire
Timepoint [3] 381663 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [4] 381664 0
Pain measured using the Faces Pain Scale
Timepoint [4] 381664 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [5] 381665 0
Quality of Life measured using the General Health Questionnaire
Timepoint [5] 381665 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [6] 381666 0
Weight (self-reported)
Timepoint [6] 381666 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [7] 381668 0
Number of other medications taken (self-reported via the survey and collected via medical records)
Timepoint [7] 381668 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [8] 381669 0
Dose of other medications taken (more, same or less than before started medicinal cannabis) measured by self-report through the survey and medical records
Timepoint [8] 381669 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [9] 381670 0
Side effects self-reported using an open-ended question, and collected from medical records. Side effects may include fatigue and sedation, vertigo, nausea and vomiting, fever, decreased or increased appetite, dry mouth, and diarrhoea, however in order to capture information regarding side effects that may not yet be known in relation to these products, this question will be left open-ended.
Timepoint [9] 381670 0
Upon first completion of the survey then at 2 weeks, one month, 3 months, 6 months and 12 months after first completion
Secondary outcome [10] 381671 0
Symptom severity measured using the question: Do you experience more or less severe symptoms for your condition now compared to before you started treatment with medicinal cannabis? (much more severe now/ more severe now/ same / less now/ much less
now)
Timepoint [10] 381671 0
2 weeks, one month, 3 months, 6 months and 12 months after first completion

Eligibility
Key inclusion criteria
Participants will be any patient who has been prescribed medicinal cannabis through the Special Access Scheme B via Cannvalate and their medical practitioner. Participants may be taking cannabis in any dose, form, duration and frequency, and for any condition. Patients of all ages and genders may participate.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The only exclusion criterion is that a person not having been prescribed medicinal cannabis may not participate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305362 0
Commercial sector/Industry
Name [1] 305362 0
Cannvalate (Australia)
Address [1] 305362 0
C2 Level 1/459 Toorak Rd,
Toorak
VIC 3142
Australia
Country [1] 305362 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cannvalate (Australia)
Address
Suite D,
Tok H Centre,
459 Toorak Road,
Toorak VIC 3142
Country
Australia
Secondary sponsor category [1] 305735 0
University
Name [1] 305735 0
Swinburne University of Technology
Address [1] 305735 0
PO Box 218
Hawthorn
VIC 3122
Country [1] 305735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305695 0
Swinburne University Human Research Ethics Committee [EC00240]
Ethics committee address [1] 305695 0
Research Ethics, Integrity and Biosafety Office
Swinburne Research (H68)
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 305695 0
Australia
Date submitted for ethics approval [1] 305695 0
Approval date [1] 305695 0
18/03/2020
Ethics approval number [1] 305695 0

Summary
Brief summary
This study aims to collect data on the efficacy of clinically prescribed cannabis products from a large-scale cohort to examine the relationships between cannabis treatment and concomitant medication use, pain, symptoms, quality of life, mood and sleep measures in a patient population that includes, but is not limited to, cancer patients.

Who is it for?
You may be eligible to join this study if you have been prescribed medicinal cannabis through the Special Access Scheme B via Cannvalate and their medical practitioner for any condition including, but not limited to, cancer. If you are under 18 years of age your parents must also consent to your participation in the project.

Study details
All eligible participants will be emailed a link to an online survey. An automated email will be sent at set intervals (2 weeks, 1 month, 3 months, 6 months, 12 months) from the date of first completion asking patients to complete the survey again. In addition, participants will be asked whether they consent to the investigators accessing their medical records in order to store data in a research database for this and future projects. Participants may choose to participate in one component of the study without the other (e.g. complete survey but not consent to medical records access or vice versa).

The survey will take approximately 45 minutes to complete and will be a compilation of the following questions and questionnaires: Demographics, Medical Condition that cannabis is prescribed, dosage, duration and administration of cannabis treatment, general health, pain, symptoms, quality of life, mood and sleep measures.

It is hoped that this research will contribute to the knowledge of the safety and efficacy of medicinal cannabis products for different medical conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101258 0
A/Prof Luke Downey
Address 101258 0
Centre for Human Psychopharmacology
Mail H99
Swinburne University
PO Box 218
Hawthorn
VIC 3122
Country 101258 0
Australia
Phone 101258 0
+61 3 9214 5781
Fax 101258 0
Email 101258 0
ldowney@swin.edu.au
Contact person for public queries
Name 101259 0
Dr Sarah Catchlove
Address 101259 0
Centre for Human Psychopharmacology
Mail H24
Swinburne University
PO Box 218
Hawthorn
VIC 3122
Country 101259 0
Australia
Phone 101259 0
+61 3 9214 5483
Fax 101259 0
Email 101259 0
scatchlove@swin.edu.au
Contact person for scientific queries
Name 101260 0
Dr Sarah Catchlove
Address 101260 0
Centre for Human Psychopharmacology
Mail H24
Swinburne University
PO Box 218
Hawthorn
VIC 3122
Country 101260 0
Australia
Phone 101260 0
+61 3 9214 5483
Fax 101260 0
Email 101260 0
scatchlove@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
This is a collaborative project and there may be restrictions on the sharing of intellectual property from the industry collaborator. It is therefore not expected that IPD will be made available. However, if required by the publishing journal, de-identified data may be uploaded to an appropriate repository. Individual health data will not be made available for confidentiality reasons.
What supporting documents are/will be available?
No other documents available
Summary results
No Results