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Trial registered on ANZCTR


Registration number
ACTRN12622000390785
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
7/03/2022
Date last updated
21/12/2022
Date data sharing statement initially provided
7/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Project Twenty21 Australia- A Prospective Observational Study Investigating Medicinal Cannabis in Four Clinical Conditions
Scientific title
Project Twenty21 Australia: A Prospective, Real-World Observational Cohort Study to Investigate the Efficacy of Medicinal Cannabis
Secondary ID [1] 306290 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 325050 0
chronic pain 325051 0
post traumatic stress disorder 325052 0
multiple sclerosis 325053 0
Condition category
Condition code
Mental Health 322486 322486 0 0
Anxiety
Mental Health 322487 322487 0 0
Other mental health disorders
Musculoskeletal 322489 322489 0 0
Other muscular and skeletal disorders
Neurological 322490 322490 0 0
Multiple sclerosis

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 be conducted to observe patients for up to 6 months after receiving cannabis medicines for the treatment of one of four conditions: chronic pain, anxiety, PTSD and MS. The study will be conducted over 2022 and 2023, with recruitment ending at the end of May 2023 and data collection ending at the end of November 2023. The study will collect demographic data including gender, age, as well as medical condition, height/weight/BMI, and current medications at baseline- this is collected via an online form emailed to the participant after signing their informed consent form. This information is automatically uploaded to the study database. Participants will complete online questionnaires at baseline, then 3 months and 6 months. Recruitment for the study will end at the end of May 2023 and the study data collection will end at the end of November 2023. The questionnaires will take approximately 15-20 minutes to complete. Participants complete a questionnaire specific to their condition (ie. for chronic pain, MS, anxiety, PTSD)- there are two questionnaires for MS. Participants also complete questionnaires assessing quality of life, sleep, depression/mood, two questionnaires about side effects and behavioural changes, and a questionnaire about impact of treatment. To assess safety, pathology (blood) tests are conducted at baseline, then at 6 months.
Intervention code [1] 322724 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330272 0
In chronic pain patients: efficacy in alleviating chronic pain is assessed using the Brief Pain Inventory Short Form (BPI-SF), a common validated questionnaire for evaluating chronic pain, including pain severity and interference of pain on feeling and function. For most of the questions, participants tick a box (10 point Likert scale, 0-10) to rate their pain and the impact that their pain has on them.
Timepoint [1] 330272 0
Assessment of chronic pain is conducted at baseline (prior to medicinal cannabis use) then at 3 months and 6 months.
Primary outcome [2] 330273 0
In patients with MS, primary outcome will be efficacy in alleviating chronic pain associated with MS, as measured using the Brief Pain Inventory Short Form (BPI-SF). This is a common validated questionnaire for evaluating chronic pain, including pain severity and interference of pain on feeling and function. For most of the questions, participants tick a box (10 point Likert scale, 0-10) to rate their pain and the impact that their pain has on them.
Timepoint [2] 330273 0
Assessment is conducted at baseline (prior to medicinal cannabis use) then at 3 months and 6 months.
Primary outcome [3] 330274 0
In patients with anxiety as their primary symptom/condition, the primary outcome will be efficacy in reducing anxiety as measured by score on the Generalised Anxiety Disorder 7 (GAD-7), one of the most commonly used, validated self-reported questionnaires used to assess anxiety. This asks patients to rate on a 4 point Likert scale (0,1,2,3) how often they have been bothered by particular problems.
Timepoint [3] 330274 0
Assessment is .conducted at baseline (prior to medicinal cannabis use) then at 3 months and 6 months
Secondary outcome [1] 405544 0
Quality of life will be assessed using the the Euro Quality of Life 5 Dimensions (EQ-5D). This is a widely used, validated, reliable health-related quality of life tool that measures quality of life through assessment of the severity of each of the five following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of these items is assessed on a five-point Likert scale.
Timepoint [1] 405544 0
Assessment is conducted at baseline (prior to medicinal cannabis use) then at 3 months, and 6 months,
Secondary outcome [2] 405545 0
Safety is assessed via conduct of pathology tests (full blood examination, liver function tests and urea and electrolytes). Change from baseline results at 6 months and 12 months for all markers is recorded and assessed.
Timepoint [2] 405545 0
Pathology tests are conducted at baseline, then 6 months after commencing medicinal cannabis. Pathology tests are assessed by the treating doctor.
Secondary outcome [3] 407033 0
Impact on sleep will be assessed using a sleep questionnaire that has been adapted from the widely used Pittsburgh Sleep Quality Index. There are four items, each assessed on a five-point scale.
Timepoint [3] 407033 0
Baseline, and 3 months and 6 months after commencing medicinal cannabis.
Secondary outcome [4] 407034 0
Mood/depression is assessed using the Patient Health Questionnaire (PHQ-9), which is a reliable and valid measure of depression severity, that has been validated in general populations, medical populations and psychiatric populations. It is a 9-item self-rating scale that assesses the frequency of depressive symptomatology during the previous two weeks on a four-point Likert scale (0 = not at all; 1 = several days; 2= over half the days; 3=nearly every day). These items are summed to form an overall measure of depressive symptomatology.
Timepoint [4] 407034 0
Baseline, and 3 months and 6 months after commencing medicinal cannabis.
Secondary outcome [5] 407037 0
Impact of treatment is assessed via the Patients’ Global Impression of Change (PGIC) questionnaire, a validated instrument that assesses impact of treatment. It asks participants to rate impact of treatment on symptoms, activity limitations, quality of life, and emotions on a Likert Scale of 1-7. It also asks participants to circle a number from 0-10 that matches the degree of change since beginning care at the clinic.
Timepoint [5] 407037 0
3 months and 6 months after commencing medicinal cannabis.
Secondary outcome [6] 407087 0
Score on the Multiple Sclerosis Rating Scale (Revised) (MSRS-R). The MSRS-R is a validated questionnaire that asks patients to rate on a 5 point Likert scale (0-4) how MS impacts on 8 different functions (walking, using arms/hands, vision, speaking clearly, swallowing, bowel/bladder, thinking/ memory/ cognition, and numbness/ tingling/ burning sensation/pain).
Timepoint [6] 407087 0
Baseline, and 3 months and 6 months after commencing medicinal cannabis.
Secondary outcome [7] 407089 0
Score on The Cannabis Based Medicines Questionnaire which asks 10 questions about side effects and behavioural consequences of the use of cannabis medicines, 8 of which are on a 5 point Likert scale, and 2 of which are on a 3 point Likert scale.
Timepoint [7] 407089 0
3 months and 6 months after commencement of cannabis medicine.
Secondary outcome [8] 407090 0
Safety secondary outcome: A Symptom Questionnaire which includes a drop-down menu of positive side effects and also asks the participant to state if they have had an adverse effects and to list those. Outcomes will be simply frequency data on adverse events.
Timepoint [8] 407090 0
3 months and 6 months after commencement of cannabis medicine.
Secondary outcome [9] 407091 0
This is actually a PRIMARY OUTCOME VARIABLE
Efficacy in alleviating symptoms associated with PTSD as measured by the Post traumatic Stress Disorder Checklist-Civilian Version (PLC-C). The PLC-C is a reliable and validated tool which is widely used to assess self-reported change in PTSD symptoms. It has 15 statements and participants are asked to indicate how much they are bothered by a particular symptom, choosing a response which ranges from not all (0) to extremely (5) (5 point Likert scale).
Timepoint [9] 407091 0
Baseline, 3 months, and 6 months after commencement of cannabis medicine.

Eligibility
Key inclusion criteria
1. Patients, females and males, aged 18 years and over with a diagnosis which falls under one of the following four study categories: chronic pain, anxiety, PTSD, and multiple sclerosis and who are prescribed medicinal cannabis as per standard clinical practice by a clinician at Releaf Clinics.
2. In the professional opinion of the treating clinician, the patient is eligible to be prescribed medicinal cannabis in Australia.
3. Ability to fully understand the potential side effects associated with medicinal cannabis, and the fact that driving with any amount of THC in your system is an offence under Australian driving laws in all states and territories
4. Ability to fully understand the requirements of participation in the study.
5. Provide written informed consent to participate in the study and are willing to comply with the study procedures.
6. Agree to be prescribed medicinal cannabis products from the Project Formulary.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients currently using recreational cannabis (where use is chronic and more than three days per week for the past 2 months) or medicinal cannabis for medical reasons
2. Evidence of clinically relevant haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic or psychiatric disorder which in the opinion of the medical practitioner should preclude them from participating in the study.
3. Known allergy to medicinal cannabis, CBD or any of the components of the medicinal cannabis products in the Project Formulary.
4. Pregnancy or active breast feeding.
5. Clinically significant abnormalities in baseline laboratory test results including liver function and kidney function: Creatinine > 1.5 times upper limit of normal; ALT, AST or ALP > 2 times upper limit of normal.
6. Taking warfarin or any other blood thinning medication (which may interact adversely with CBD).
7. Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to inclusion.
8. Unwilling or unable to provide written informed consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As an exploratory real-world study, the study is intended to provide data about several outcome variables over a 6-month period. The outcomes of this study may also be used to assist in the design of a subsequent larger-scale RCT. It is anticipated that around 500 will be recruited over the recruitment time-period *early 2022 to end of May 2023).
Within each of the four clinical conditions examined in this study, primary endpoints will be the questionnaire scores for each of the condition-specific questionnaires. Secondary endpoints will be the scores from the general questionnaires.

Descriptive statistics will be provided for demographic data (age, height, weight, body mass index).
Data will be aggregated in order to conduct within-groups analyses to assess changes in outcome variables within each of the four conditions, comparing mean outcomes of questionnaire scores with baseline at 3 and 6 months. The data will be checked for normality. Where data is normal, the Paired Student T-test will be used. Where data is non-normal, the non-parametric equivalent of this test, the Wilcoxon Signed Ranks Test will be used. Safety and tolerability data and any changes in blood tests will be reported as frequency data.
Other statistical methods will include analyses of the repeated measures data to examine changes in symptomatology over time, regression-based methods and trajectory-based methods, such as latent trajectory analyses. Such methods allow for the identification of specific symptom trajectories (e.g., gradual reduction in symptoms vs. rapid reduction) and examination of whether individuals following these different trajectories vary on personal characteristics (e.g., gender, symptom intensity at start of treatment) or treatment characteristics (e.g., product type, dose).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/01/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
500
Accrual to date
183
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment postcode(s) [1] 36486 0
3182 - St Kilda
Recruitment postcode(s) [2] 36487 0
4006 - Fortitude Valley
Recruitment postcode(s) [3] 36489 0
4567 - Noosa Heads
Recruitment postcode(s) [4] 36490 0
4551 - Caloundra
Recruitment postcode(s) [5] 38700 0
4225 - Coolangatta
Recruitment postcode(s) [6] 38701 0
4101 - West End
Recruitment postcode(s) [7] 39187 0
3204 - Bentleigh

Funding & Sponsors
Funding source category [1] 310638 0
Commercial sector/Industry
Name [1] 310638 0
Releaf Dispensaries Pty Ltd
Country [1] 310638 0
Australia
Funding source category [2] 310640 0
Commercial sector/Industry
Name [2] 310640 0
ADELAIDE COMPOUNDING PHARMACY (INT) PTY LTD
Country [2] 310640 0
Australia
Funding source category [3] 310641 0
Commercial sector/Industry
Name [3] 310641 0
Beacon Medical Australia Pty Ltd
Country [3] 310641 0
Australia
Funding source category [4] 310642 0
Commercial sector/Industry
Name [4] 310642 0
Levin Health Ltd
Country [4] 310642 0
Australia
Funding source category [5] 310643 0
Commercial sector/Industry
Name [5] 310643 0
Cann Global Pty Ltd
Country [5] 310643 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Releaf Training and Education trading as the Australasian College of Cannabinoid Medicine
Address
Level 1, 82 Acland St, St Kilda, Vic 3182
Country
Australia
Secondary sponsor category [1] 311850 0
None
Name [1] 311850 0
Address [1] 311850 0
Country [1] 311850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310239 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 310239 0
Ethics committee country [1] 310239 0
Australia
Date submitted for ethics approval [1] 310239 0
29/10/2021
Approval date [1] 310239 0
20/12/2021
Ethics approval number [1] 310239 0
0097E_2021

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

Contacts
Principal investigator
Name 116962 0
Dr Dr Sylvia Victor
Address 116962 0
Releaf Group Ltd
L1/82 Acland St
St Kilda
Vic 3182
Country 116962 0
Australia
Phone 116962 0
+61 429868616
Fax 116962 0
Email 116962 0
sylvia@releafgroupltd.com
Contact person for public queries
Name 116963 0
Michelle Frans
Address 116963 0
Releaf Group Ltd
L1/82 Acland St
St Kilda
Vic 3182
Country 116963 0
Australia
Phone 116963 0
+61 3 99880878
Fax 116963 0
Email 116963 0
michelle@releafgroupltd.com
Contact person for scientific queries
Name 116964 0
Sylvia Victor
Address 116964 0
Releaf Group Ltd
L1/82 Acland St
St Kilda
Vic 3182
Country 116964 0
Australia
Phone 116964 0
+61 429868616
Fax 116964 0
Email 116964 0
sylvia@releafgroupltd.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sponsoring companies will have access to raw data as it pertains to their medicinal cannabis products only.


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.