Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000149662
Ethics application status
Approved
Date submitted
30/01/2023
Date registered
15/02/2023
Date last updated
15/02/2023
Date data sharing statement initially provided
15/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study investigating the safety, tolerability and health outcomes of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions
Scientific title
An observational study investigating the safety, tolerability and health outcomes of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions
Secondary ID [1] 308861 0
None
Universal Trial Number (UTN)
Trial acronym
CMR-OBS-001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Any recognized condition for which medicinal cannabis could be prescribed for 328833 0
Chronic Pain 328834 0
Anxiety 328835 0
Insomnia 328836 0
Post-traumatic stress disorder 328837 0
Dementia 328840 0
Parkinson's disease/Tremor 328841 0
Seizure management/Epilepsy 328842 0
Neuropathic pain 328843 0
Mood Disorder 328844 0
Autism 328845 0
Inflammatory bowel disease/Irritable bowel syndrome 328846 0
Chemotherapy-induced nausea and vomiting 328847 0
Condition category
Condition code
Anaesthesiology 325833 325833 0 0
Pain management
Mental Health 325834 325834 0 0
Anxiety
Neurological 325835 325835 0 0
Epilepsy
Mental Health 325836 325836 0 0
Other mental health disorders
Neurological 325838 325838 0 0
Parkinson's disease
Neurological 325841 325841 0 0
Other neurological disorders
Cancer 325845 325845 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational, single center investigator driven study conducted in Australia with patients who are about to start cannabinoid therapy for management of recognized chronic
conditions. Patients are to be enrolled into the study no earlier than their Physician’s decision to initiate treatment with a cannabinoid therapy. It is mandatory that the prescriber’s decision to start treatment with cannabinoid therapy was taken independently and before presenting the patient the option to participate in the study. Participants will be followed monthly for a maximum of 12 months from the signing of the informed consent forms (PISCF) or until death, withdrawal of consent, loss of follow-up/record, whichever comes first. During the follow-up visits, assessments will be performed according to routine local clinical practice. Data collected at each visit for the study may include:
- Change in concomitant medications and rationale
- Kessler Psychological Distress Scale (K10) score
- Insomnia Severity Index score
- Simple Pain Index score
- Kemp Quality of Life Scale score
- Rationale for change in cannabinoid therapy and/or dose if applicable
- Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy
- Adverse Events/Serious Adverse Events/Adverse Drug reaction that may have occurred while on the study
Follow-up patient reports detailing the required information will be completed for a maximum of 12 months (Reports to coincide with patient visit for follow-up consultation and/or new cannabinoid therapy prescription).
Intervention code [1] 325306 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333677 0
The primary scientific objective of this project is to investigate the safety and tolerability characteristics of cannabinoid therapy prescribed to eligible patients for management of recognized chronic conditions. Safety and tolerability are measured through collection and reporting of adverse events. Information on severity, seriousness and relationship to medical cannabinoid treatment will be used to measure the tolerability and safety of any given dose. Like all prescription medicines, medicinal cannabis products can have side effects. These may include:
- Fatigue and sedation
- Vertigo
- Nausea and vomiting
- Fever
- Appetite increase or decrease
- Dry mouth
- Diarrhoea
- Convulsions
- Feelings of euphoria (intense happiness) or depression confusion
- Hallucinations or paranoid delusions
- Psychosis or cognitive distortion (having untrue thoughts)

Adverse event / serious adverse event data is collected at each visit through subject reporting of symptoms, collection of any relevant medical records / GP letters, and laboratory/pathology results. Adverse event information is documented via the observational trial specific adverse event log that is maintained by the treating physician.
Timepoint [1] 333677 0
Once a month for twelve months.
Primary outcome [2] 333678 0
Participant withdrawal from the study and/or reason for discontinuation of cannabinoid therapy. This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records.
Timepoint [2] 333678 0
Once a month for twelve months.
Primary outcome [3] 333679 0
Number of doses consumed since previous visit (tolerability). This is assessed and reported by the treating physician at each visit via completion of observational trial worksheets and patient medical records
Timepoint [3] 333679 0
Once a month for twelve months.
Secondary outcome [1] 417913 0
Change in Anxiety and Depression Checklist (K10 Questionnaire) score (to quantify efficacy and changes in mood throughout the study)
Timepoint [1] 417913 0
Months 1-3, 6, 9 and 12 post enrollment into the study.
Secondary outcome [2] 417914 0
Change in Brief Pain Inventory score (to quantify efficacy and changes in pain throughout the study)
Timepoint [2] 417914 0
Months 1-3, 6, 9 and 12 post enrollment into the study.
Secondary outcome [3] 417915 0
Change in Kemp quality of life score (to evaluate efficacy and changes in quality of life throughout the study)
Timepoint [3] 417915 0
Months 1-3, 6, 9 and 12 post enrollment into the study.
Secondary outcome [4] 417916 0
Change in insomnia severity index score (to quantify efficacy and change in insomnia throughout the study)
Timepoint [4] 417916 0
Months 1-3, 6, 9 and 12 post enrollment into the study.
Secondary outcome [5] 417917 0
Concomitant Medications and changes thereof (composite secondary outcome) Concomitant medications are reported by the subject and available medical records. Concomitant medications and changes thereof are documented on an observational trial specific medication log.
Timepoint [5] 417917 0
Once a month for twelve months.
Secondary outcome [6] 417918 0
Cannabinoid therapy dose, indication, and rationale for changes in dosage.(composite secondary outcome).
Dosing information is reported by the treating physician via observational trial specific worksheets
Timepoint [6] 417918 0
Once a month for twelve months.
Secondary outcome [7] 417919 0
Rationale for cannabinoid therapy prescription/administration (symptoms and chronic condition description)
This is reported by the subject at time of enrolment and assessed by the treating physician after reviewing available medical records. Information regarding this outcome is documented via observational trial specific worksheets.
Timepoint [7] 417919 0
Once a month for twelve months.

Eligibility
Key inclusion criteria
1. Prospective participants must be greater than to equal to 18 years of age at time of entry on study
2. Prospective participants must be willing and able to understand the informed consent process, provide informed consent, and participate in the observational study
3. Prospective participants must be eligible to be lawfully prescribed cannabinoid therapy by their Physician
4. Prospective participants agree to abstain from using cannabinoid therapy other than the therapy that is prescribed by their Physician
Minimum age
18 Years
Maximum age
101 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prospective participants are ineligible if they are under the age of 18
2. Prospective participants are ineligible if they are unwilling, unable or cannot understand the informed consent form
3. Prospective participants are ineligible if their Physician determines that the prospective participant is unable to fulfill any requirements of the study
4. Prospective participants are ineligible if they are currently using illicit drugs and/or with alcohol abuse.
5. Prospective patients are ineligible if any of the following are met:
5.1. Have an active or previous psychotic or active mood or anxiety disorder
5.2. Women who are pregnant, planning to become pregnant or breastfeeding
5.3. Have unstable cardiovascular disease

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is descriptive in nature and no formal hypotheses will be tested. As this is not a study with pre-specified hypotheses, no comparative analyses assessing the effectiveness of other treatments will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313082 0
Commercial sector/Industry
Name [1] 313082 0
Cloud Medical PTY LTD
Country [1] 313082 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cloud Medical PTY LTD
Address
73 Angove St, North Perth WA 6006
Country
Australia
Secondary sponsor category [1] 314770 0
None
Name [1] 314770 0
Address [1] 314770 0
Country [1] 314770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312328 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 312328 0
Ethics committee country [1] 312328 0
Australia
Date submitted for ethics approval [1] 312328 0
08/11/2022
Approval date [1] 312328 0
24/01/2023
Ethics approval number [1] 312328 0
0117E_2022

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

Contacts
Principal investigator
Name 124270 0
Dr Kane Della Vedova
Address 124270 0
Cloud Medical
73 Angove St, North Perth WA 6006
Country 124270 0
Australia
Phone 124270 0
+61 8 9334 6968
Fax 124270 0
Email 124270 0
[email protected]
Contact person for public queries
Name 124271 0
Lewis Edwards
Address 124271 0
Cloud Medical
73 Angove St, North Perth WA 6006
Country 124271 0
Australia
Phone 124271 0
+61 08 9334 6989
Fax 124271 0
Email 124271 0
[email protected]
Contact person for scientific queries
Name 124272 0
Lewis Edwards
Address 124272 0
Cloud Medical
73 Angove St, North Perth WA 6006
Country 124272 0
Australia
Phone 124272 0
+61 08 9334 6989
Fax 124272 0
Email 124272 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


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.