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Trial registered on ANZCTR
Registration number
ACTRN12621000875808
Ethics application status
Approved
Date submitted
20/05/2021
Date registered
6/07/2021
Date last updated
6/07/2021
Date data sharing statement initially provided
6/07/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
A clinical audit of opioid reduction in patients undergoing treatment with medicinal cannabis for chronic non-cancer pain
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Scientific title
A clinical audit of opioid reduction in patients undergoing treatment with medicinal cannabis for chronic non-cancer pain
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Secondary ID [1]
304272
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic non-cancer pain
322003
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Condition category
Condition code
Neurological
319722
319722
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0
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Other neurological disorders
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Musculoskeletal
320013
320013
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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Description of intervention(s) / exposure
Patients referred to Dr Finch's chronic pain management clinic for treatment of non-cancer pain where appropriate are treated with medicinal cannabis. Many of these patients are already taking opioid drugs (morphine-like drugs), which seldom control their pain and in many cases are deleterious to their health.
This study will evaluate outcomes in a group taking both opioids and cannabinoids in comparison to a group taking opioids but not taking cannabinoids at 6-month intervals for up to 2 years post-enrolment. Assessments will include a pain diagram, the numerical pain rating score, Oswestry Disability Index (ODI), their insomnia severity (ISI) and their medication history, especially opioid consumption. The assessments take up to 20 minutes to complete. Participants will attend a face-to-face session to complete the questionnaires at the Perth Pain Management Centre, or via videoconference. Questionnaires will be administered in the waiting room before a consultation with a pain specialist, or will be completed via email before a telehealth consultation.
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Intervention code [1]
320614
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Not applicable
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Comparator / control treatment
The comparison group will take opioids but not cannabinoids over the 2-year period of the clinical audit.
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Control group
Active
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Outcomes
Primary outcome [1]
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Opioid consumption (oMEDD score - oral morphine equivalent daily dose)
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Assessment method [1]
327591
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Timepoint [1]
327591
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Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment.
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Secondary outcome [1]
395815
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numerical pain rating
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Assessment method [1]
395815
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Timepoint [1]
395815
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Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
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Secondary outcome [2]
395816
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Oswestry Disability Index (ODI)
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Assessment method [2]
395816
0
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Timepoint [2]
395816
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Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
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Secondary outcome [3]
395817
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insomnia severity index (ISI)
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Assessment method [3]
395817
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Timepoint [3]
395817
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Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
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Secondary outcome [4]
395818
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depression, anxiety and stress (DASS)
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Assessment method [4]
395818
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Timepoint [4]
395818
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Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
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Eligibility
Key inclusion criteria
Chronic non-cancer patients referred to Perth Pain Management Centre or to Dr Michael Kent who were taking opioid medications at or after the commencement of the audit (November 2020).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cannabinoid exclusion - previous significant drug addiction, pregnancy, lactation, previous psychotic illness, age (under 18) and relative exclusions of heart and liver disease.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
All patients who meet inclusion criteria will be invited to participate in the clinical audit during the study period. The number of patients in each group is uncertain but is likely to be greater than 100.
Changes in pain, sleep and other outcome measures will be investigated in Group (cannabis versus opioids only) by Time (baseline versus follow-up) repeated measures analyses of variance.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/11/2020
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
29/12/2023
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Actual
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Sample size
Target
200
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Accrual to date
30
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment postcode(s) [1]
34109
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6151 - South Perth
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Funding & Sponsors
Funding source category [1]
308649
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Self funded/Unfunded
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Name [1]
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Dr Finch
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Address [1]
308649
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Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
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Country [1]
308649
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Australia
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Funding source category [2]
308884
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University
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Name [2]
308884
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Murdoch University
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Address [2]
308884
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90 South Street, Murdoch, 6150, Western Australia
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Country [2]
308884
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Australia
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Primary sponsor type
Individual
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Name
Dr Philip Finch
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Address
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
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Country
Australia
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Secondary sponsor category [1]
309524
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University
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Name [1]
309524
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Murdoch University
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Address [1]
309524
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90 South Street, Murdoch, 6150, Western Australia
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Country [1]
309524
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308575
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Murdoch University Human Research Ethics Committee
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Ethics committee address [1]
308575
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90 South Street, Murdoch, 6150, Western Australia
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Ethics committee country [1]
308575
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Australia
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Date submitted for ethics approval [1]
308575
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Approval date [1]
308575
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19/05/2021
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Ethics approval number [1]
308575
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2021-008
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Summary
Brief summary
Patients referred to the chief investigator’s chronic pain management clinic where appropriate are treated with medicinal cannabis. Many of these patients are already taking opioid drugs (morphine-like drugs), which seldom control their pain and in many cases are deleterious to their health. This study will evaluate outcomes in a group taking both opioids and cannabinoids in comparison to a group taking opioids but not taking cannabinoids.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
111194
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Dr Philip Finch
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Address
111194
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Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
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Country
111194
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Australia
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Phone
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+61 8 93672233
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Fax
111194
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Email
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[email protected]
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Contact person for public queries
Name
111195
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Dr Philip Finch
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Address
111195
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Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
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Country
111195
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Australia
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Phone
111195
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+61 8 93672233
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Fax
111195
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Email
111195
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[email protected]
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Contact person for scientific queries
Name
111196
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Dr Philip Finch
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Address
111196
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Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
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Country
111196
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Australia
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Phone
111196
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+61 8 93672233
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Fax
111196
0
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Email
111196
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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