Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000718943p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2020
Date registered
2/07/2020
Date last updated
2/07/2020
Date data sharing statement initially provided
2/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabinoid Medicine Observational Study (CMOS): Observation of cannabinoid prescribing and dosage patterns in Australian clinical practice
Scientific title
Cannabinoid Medicine Observational Study (CMOS): A prospective, open-label, observational study of cannabinoid prescribing and dosage patterns in Australian clinical practice.
Secondary ID [1] 301397 0
None
Universal Trial Number (UTN)
U1111-1252-7386
Trial acronym
CMOS (Cannabinoid Medicine Observational Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-cancer pain 317656 0
Cancer pain 317657 0
Anxiety disorders 317658 0
Epilepsy 317659 0
Sleep disorders 317660 0
Multiple Sclerosis 317661 0
Palliative care 317662 0
Mental Health 317664 0
Gastrointestinal disorders 317665 0
Anxiety disorders 317868 0
Chemotherapy-induced nausea and vomiting (CINV) 317869 0
Condition category
Condition code
Alternative and Complementary Medicine 315740 315740 0 0
Other alternative and complementary medicine
Public Health 315741 315741 0 0
Other public health
Mental Health 315747 315747 0 0
Anxiety
Neurological 315749 315749 0 0
Epilepsy
Neurological 315750 315750 0 0
Multiple sclerosis
Musculoskeletal 315751 315751 0 0
Other muscular and skeletal disorders
Cancer 315912 315912 0 0
Any cancer
Mental Health 315913 315913 0 0
Other mental health disorders
Oral and Gastrointestinal 315914 315914 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant).

Participants will be asked to complete a total of 14 questionnaires at set time points throughout the study. The study progress questionnaire including additional validated measures of health-related quality of life, medication adherence and patient reported change will be completed at enrolment, and months 1, 3, 6, 9 and 12 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment).
A short-form questionnaire focused on side effect reporting, current dose and changes to other concomitant medications will be completed at months 2, 4, 5, 7, 8, 10 and 11 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment).

It is anticipated that each questionnaire will take between 5-30 minutes to complete, requiring a total of 30 minutes maximum participation each month for the 12 months of the study.

Clinicians will be asked to complete the baseline enrolment form (10 minutes to complete) for each patient at study enrolment as well as adverse event monitoring questionnaires, each taking 5-10 minutes to complete every 3 months for the period that they have patients enrolled in the study.

Intervention code [1] 317704 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323953 0
The type of medicinal cannabis product/s prescribed (including the formulation, prescribed dosage and underlying medical condition) as collected by study-specific questionnaires.
Timepoint [1] 323953 0
Collected at baseline, and then monthly for a 12 month period post-enrolment.
Primary outcome [2] 324126 0
Number of adverse and serious adverse events experienced that are related to medicinal cannabis treatment, including but not limited to, dry mouth, somnolence and gastrointestinal upset, as measured by study-specific questionnaires. These will be captured by clinicians at clinical examinations and also reported by patients on a monthly basis using the safety reporting questionnaire. The safety reporting questionnaires being used are study specific. The clinician AE reporting questionnaire is based on the TGA recommended guidelines for AE reporting which conform to WHO grading and causality definitions.
Timepoint [2] 324126 0
Patient reported data collected at baseline, and then monthly for a 12 month period post-enrolment.
Clinician reported data collected at 3, 6, 9 and 12 months post-enrolment.
Primary outcome [3] 324127 0
Change to patient-reported concomitant medications (including opioid use) over the observational period using study-specific questionnaires.
Timepoint [3] 324127 0
Completed at baseline, and then monthly for 12 months post-enrolment.
Secondary outcome [1] 383417 0
Change from Baseline in individual PROMIS-29 domain scores (pain, depression, anxiety, social functioning, sleep disturbance, fatigue, physical function) including total score as a measure for health-related quality of life;
Timepoint [1] 383417 0
Collected at baseline, and months 1, 3, 6, 9 and 12 post-enrolment.
Secondary outcome [2] 383418 0
Change from Baseline in Medication Adherence Rating Scale (MARS-5) score specific to medicinal cannabis adherence.
Timepoint [2] 383418 0
Collected at baseline, and months 1, 3, 6, 9 and 12 post-enrolment.
Secondary outcome [3] 383419 0
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score in relation to medicinal cannabis treatment specifically across the observation interval.
Timepoint [3] 383419 0
Collected at 3 and 12 months post-enrolment.
Secondary outcome [4] 383420 0
Change from baseline in the Patient Global Impression of Change (PGIC) score in relation to their overall health status.
Timepoint [4] 383420 0
Collected at baseline, and then monthly for a 12 month period.
Secondary outcome [5] 383421 0
For patients with sleep disorders as primary condition group or sleep problems as a key symptom: change from baseline in Pittsburgh Sleep Quality Index (PSQI) score
Timepoint [5] 383421 0
Collected at baseline, and months 1, 3, 6, 9 and 12 post-enrolment.
Secondary outcome [6] 383422 0
For patients with psychiatric disorders as primary condition group or anxiety/depression as key symptom/s: change from baseline in Hospital Anxiety and Depression scale (HADS) score
Timepoint [6] 383422 0
Collected at baseline, and months 1, 3, 6, 9 and 12 post-enrolment.
Secondary outcome [7] 383423 0
For patients with a chronic pain-related condition as primary condition group or pain as key symptom: change from baseline in Brief Pain Inventory [BPI] score.
Timepoint [7] 383423 0
Collected at baseline, and months 1, 3, 6, 9 and 12 post-enrolment.

Eligibility
Key inclusion criteria
Seeking or already receiving medicinal cannabis therapy and deemed eligible for medicinal cannabis prescription by their treating physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent
2. Females who are pregnant or breastfeeding.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed using SPSS (v25.0, IBM Analytics). Descriptive statistics will be produced with summary data regarding participant demographics, treatment (cannabis formulation and dosage) and patient-reported outcome assessments. Continuous variables with normal distribution will be presented as means with standard deviation; non-normal distribution will be presented as medians with an interquartile range (IQR). Categorical variables will be presented as counts and per cent of the total.

The study will use t-test for the analysis of the continuous variables with normal distribution, and non-parametric Wilcoxon test used whenever parametric assumptions are not satisfied. Longitudinal outcome data overtime (i.e. changes from baseline) will be analysed using repeated measures analysis (e.g. ANOVAs or ANCOVAs to correct for any confounding variables).

Multivariate logistic regression will be used to analyse factors associated with treatment outcomes and Bonferroni-corrected to adjust for multiple testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2020
Actual
Date of last participant enrolment
Anticipated
22/07/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305837 0
Commercial sector/Industry
Name [1] 305837 0
Applied Cannabis Research
Country [1] 305837 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Applied Cannabis Research
Address
53 Walker Street, North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 306281 0
None
Name [1] 306281 0
Address [1] 306281 0
Country [1] 306281 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306101 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 306101 0
Ethics committee country [1] 306101 0
Australia
Date submitted for ethics approval [1] 306101 0
28/05/2020
Approval date [1] 306101 0
Ethics approval number [1] 306101 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102710 0
Dr John Barlow
Address 102710 0
Applied Cannabis Research
53 Walker Street, North Sydney NSW 2060
Country 102710 0
Australia
Phone 102710 0
+61 2 8294 6406
Fax 102710 0
Email 102710 0
[email protected]
Contact person for public queries
Name 102711 0
Melissa Benson
Address 102711 0
Applied Cannabis Research
53 Walker Street, North Sydney NSW 2060
Country 102711 0
Australia
Phone 102711 0
+61 2 8294 6406
Fax 102711 0
Email 102711 0
[email protected]
Contact person for scientific queries
Name 102712 0
Melissa Benson
Address 102712 0
Applied Cannabis Research
53 Walker Street, North Sydney NSW 2060
Country 102712 0
Australia
Phone 102712 0
+61 2 8294 6406
Fax 102712 0
Email 102712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This project includes collection of data that is commercially sensitive and as such there may be restrictions on the sharing of intellectual property/data. De-identified aggregate data may be shared via an appropriate data repository if required by any peer-reviewed journal, in relation to publication of any study findings.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.