Trial Review

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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
Scientific title
A clinical audit of opioid reduction in patients undergoing treatment with medicinal cannabis for chronic non-cancer pain
Secondary ID [1] 304272 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic non-cancer pain 322003 0
Condition category
Condition code
Neurological 319722 319722 0 0
Other neurological disorders
Musculoskeletal 320013 320013 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
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.
Intervention code [1] 320614 0
Not applicable
Comparator / control treatment
The comparison group will take opioids but not cannabinoids over the 2-year period of the clinical audit.
Control group
Active

Outcomes
Primary outcome [1] 327591 0
Opioid consumption (oMEDD score - oral morphine equivalent daily dose)
Timepoint [1] 327591 0
Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment.
Secondary outcome [1] 395815 0
numerical pain rating
Timepoint [1] 395815 0
Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
Secondary outcome [2] 395816 0
Oswestry Disability Index (ODI)
Timepoint [2] 395816 0
Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
Secondary outcome [3] 395817 0
insomnia severity index (ISI)
Timepoint [3] 395817 0
Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment
Secondary outcome [4] 395818 0
depression, anxiety and stress (DASS)
Timepoint [4] 395818 0
Baseline, 6 months, 12 months, 18 months and 24 months post-enrolment

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
200
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 34109 0
6151 - South Perth

Funding & Sponsors
Funding source category [1] 308649 0
Self funded/Unfunded
Name [1] 308649 0
Dr Finch
Country [1] 308649 0
Australia
Funding source category [2] 308884 0
University
Name [2] 308884 0
Murdoch University
Country [2] 308884 0
Australia
Primary sponsor type
Individual
Name
Dr Philip Finch
Address
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
Country
Australia
Secondary sponsor category [1] 309524 0
University
Name [1] 309524 0
Murdoch University
Address [1] 309524 0
90 South Street, Murdoch, 6150, Western Australia
Country [1] 309524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308575 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 308575 0
90 South Street, Murdoch, 6150, Western Australia
Ethics committee country [1] 308575 0
Australia
Date submitted for ethics approval [1] 308575 0
Approval date [1] 308575 0
19/05/2021
Ethics approval number [1] 308575 0
2021-008

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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111194 0
Dr Philip Finch
Address 111194 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
Country 111194 0
Australia
Phone 111194 0
+61 8 93672233
Fax 111194 0
Email 111194 0
[email protected]
Contact person for public queries
Name 111195 0
Philip Finch
Address 111195 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
Country 111195 0
Australia
Phone 111195 0
+61 8 93672233
Fax 111195 0
Email 111195 0
[email protected]
Contact person for scientific queries
Name 111196 0
Philip Finch
Address 111196 0
Perth Pain Management Centre, 18 Hardy Street, South Perth, 6151, Western Australia
Country 111196 0
Australia
Phone 111196 0
+61 8 93672233
Fax 111196 0
Email 111196 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.