Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001137785
Ethics application status
Approved
Date submitted
21/06/2022
Date registered
17/08/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational Study of the Safety, Tolerability and Efficacy of Cannabidiol Oro-buccal Sprays for Treating Pain and/or Stress
Scientific title
Observational Study of the Safety, Tolerability and Efficacy of Cannabidiol Oro-buccal Sprays for Treating Pain and/or Stress

Secondary ID [1] 307043 0
MC-CS22-05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain or pain associated with chronic conditions appropriate for management with cannabidiol 326186 0
Stress conditions appropriate for management with cannabidiol 326187 0
Condition category
Condition code
Mental Health 323493 323493 0 0
Other mental health disorders
Anaesthesiology 323987 323987 0 0
Pain management

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 involve a systematic examination of participants who have been prescribed either botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays. The decision by a Participating Doctor to prescribe MC-1020 or MC-1023 for pain and/or stress for a patient will be taken independently and before the decision to give the patient the option to participate in the current study.

The study treatments are comprised of botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays.

The design of this study incorporates Doctor and Pharmacist Combined Care, this statement is reflective of both doctors and pharmacists being involved in the collection of study data, rather than a novel model of care that is being examined.

De-identified digital reports collected by the online digital platform, C-Trial, using HTTPS encryption and secure storage on an Amazon cloud service with multifactor authentication protected access. Each month participants will log in to C-Trial (a purpose-built electronic data capture platform) and complete online questionnaires.

The participant will be provided with an electronic report to complete containing the following baseline information will be recorded by the participant before being supplied with the study treatment, history of smoking, alcohol, and drug use (including cannabis), current medicinal or recreational cannabis.

Participant reports: monthly, the anticipated time needed to complete these reports each month is 20 minutes, no additional testing/ imaging is required of participants. The overall duration of participant observation is monthly from enrolment for up to 24 months post enrolment.

Participating Doctor and Participating Pharmacist induction reports include the following baseline information, History of smoking, alcohol, and drug use (including cannabis), study product indication (stress and/or pain), current and past medical history, including any mental health conditions, current medications including medicinal or recreational cannabis (concurrent medicinal or recreational cannabinoid use is excluded from this study).

Follow-Up Report the Participating Pharmacist will provide information on the study treatment current dose, changes in dosing since the last report, the rationale for changes in dosing, and planned duration of treatment. Any other cannabinoid use (medicinal or recreational; concurrent medicinal or recreational cannabinoid use is excluded from this study) and changes in other medications used for the study indication and rationale for changes in
dosing.

The participant will be provided with an electronic follow-up report to complete on a monthly basis after induction; as well as 2 weeks after induction; daily for three days after cessation of treatment; and 2 weeks after cessation of treatment. The reports will provide the following information on their current dose, changes, the rationale for changes in dosing of the study treatment and changes in other medications.

Follow-up visits with the Participating Doctor are not required unless severe or serious adverse reactions occur. For any follow-up visit that does occur (such as provision of study treatment continuation scripts), assessments will be performed and the Participating Doctor will complete forms including prescribed dose and rationale for changes in dosing of the study treatment, changes in other medications, and follow up on any adverse events.

The Participant and the Participating Pharmacist will receive an email and/or SMS when their respective reports are open to being completed. If a Participant or Participating Pharmacist report has remained uncompleted for 3 working days, the Participant or Participating Pharmacist will receive a reminder email and/or SMS. If a Participant is not assessed by the Participating Pharmacist within the month a Participating Pharmacist Follow-Up Report must be submitted.
Intervention code [1] 324141 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331239 0
The incidence, type and severity of adverse events will be determined for the entire cohort and among subgroups defined by indication, baseline characteristics and by concomitant medications (between-subgroup comparison). All adverse events will be included in the safety evaluation, and major safety concerns will include drug-drug interactions, hepatotoxicity, cognitive effects, psychiatric events (new or exacerbation of suicidal ideation, depression, anxiety, and psychosis), acute coronary syndrome, cardiac arrythmias, cerebral vascular accident, severe emesis, allergic reaction, increase risk of infection, drug abuse liabilities, and any serious adverse event.

Eliciting adverse event information of drug harm and tolerability rely, in part, on Participant reports of AEs, medical history and concomitant medications. A “Udvalg for Kliniske Undersøgelser” (UKU) side effects rating scale will be completed by participants in the case of an adverse event.

For the purposes of this study the Participating Doctor and Participating Pharmacist are both responsible for recording all AEs, regardless of their relationship to study drug, with the following exceptions:
1. Conditions that are present at the first study visit and do not deteriorate will not be considered adverse events.
2. Abnormal laboratory values will not be considered adverse events unless deemed clinically significant by the Participating Doctor and documented as such.

All AEs will be followed by the Participating Doctor and/or Participating Pharmacist to adequate resolution, where possible. Participating Doctors and/or Participating Pharmacists must submit all AEs using the electronic AE Log linked to their respective electronic Follow-up Reports. If a Participant experiences an AE, the Participating Pharmacist may refer the Participant to the Participating Doctor, who may suggest that the patient undergo a routine safety blood test. The Participating Doctor is only required to submit an AE log if reported during a visit and/or the Participating Doctor is notified of the AE.

AEs will be recorded from the time the Participant signs the informed consent form until the last report has been submitted to the Sponsor. Participants will be instructed to communicate the emergence of new symptoms to their Participating Doctor and/or Participating Pharmacist throughout the duration of the study. AE Logs will need to be submitted by Participating Doctors and/or Participating Pharmacists to the Sponsor with each report(if applicable). In addition, AEs will be documented from physical examination findings, clinically significant lab results or other documents that are relevant to patient safety.
Timepoint [1] 331239 0
Data collection timepoints from time of enrolment up to 2 years post enrolment.
Participant reports: once a month for 24 months
Participating Pharmacist reports: once a month for 24 months
Participating Doctor reports: as required.
Secondary outcome [1] 411192 0
Prescription changes in the study treatment and reasons for the changes will be determined. This is a non-interventional study and co-PIs are free to prescribe the study treatments as they judge appropriate. . For any follow-up visit that does occur (such provision of study treatment continuation scripts), assessments will be performed according to routine local clinical practice. Assessments include; participating doctor follow up reports as required.
Timepoint [1] 411192 0
For any follow-up visit that does occur (such as the provision of study treatment continuation scripts), assessments will be performed according to routine local clinical practice. Any Adverse events or changes in the prescription of the investigational product or other medications or participant withdrawal from the study will determine if the Participating Doctor is required to submit a report.

A Participating Doctor follow up report (if required) will be used to assess prescription changes and the reasons for those changes and will be assessed individually.
Secondary outcome [2] 412082 0
Participant withdrawal from the study and/or reason for discontinuation of investigational product assessed with side effects and withdrawal scales, including the Cannabis Withdrawal Scale (CWS).
Timepoint [2] 412082 0
Data collection timepoints from time of enrolment up to 2 years post enrolment

A Participating Doctor follow up report will be, as required, and used to assess participant withdrawals and the reasons for those withdrawals and will be assessed individually.
Secondary outcome [3] 412084 0
Changes in medications other than study treatment.
This is a non-interventional study and co-PIs are free to prescribe the study treatments as they judge appropriate.
For any follow-up visit that does occur (such as the provision of study treatment continuation scripts), assessments will be performed according to routine local clinical practice.
Timepoint [3] 412084 0
For any follow-up visit that does occur (such as the provision of study treatment continuation scripts), assessments will be performed according to routine local clinical practice. Any Adverse events or changes in the prescription of the investigational product or other medications or participant withdrawal from the study will determine if the Participating Doctor is required to submit a report.

A Participating Doctor follow up report (if required) will be used to assess prescription changes and the reasons for those changes and will be assessed individually.
Secondary outcome [4] 412085 0
Efficacy of drug in treating quality of life, assessed with quality of life questionnaire, Health-Related Quality of Life 14 (HRQOL-14)
Timepoint [4] 412085 0
Once a month for 24 months post-enrolment
Secondary outcome [5] 412086 0
Efficacy of drug in treating stress, assessed with Boston cognitive assessment (BOCA),
Timepoint [5] 412086 0
Once a month for 24 months post enrolment
Secondary outcome [6] 412355 0
Efficacy of drug in treating pain, assessed with pain questionnaire, PainDetect (PDQ)
Timepoint [6] 412355 0
Once a month for 24 months post enrolment
Secondary outcome [7] 413001 0
Patterns of cannabis-based medicine use. The data will be sourced from Doctor quarterly follow-up reports.
Timepoint [7] 413001 0
once every quarter for 24 months post-enrolment
Secondary outcome [8] 413005 0
Efficacy of drug in treating stress, assessed with Clinical Global Impression -Severity (CGI-S).
Timepoint [8] 413005 0
Data collection timepoints from time of enrolment up to 2 years post enrolment
Once a month for 24 months post enrolment
This questionnaire will be assessed individually.
Secondary outcome [9] 413006 0
Efficacy of drug in treating stress, assessed with Clinical Global Impression -Improvement (CGI-I).
Timepoint [9] 413006 0
Data collection timepoints from time of enrolment up to 2 years post enrolment
Once a month for 24 months post enrolment
This questionnaire will be assessed individually.
Secondary outcome [10] 413007 0
Efficacy of drug in treating stress, assessed with Subclinical Stress questionnaire 25 (SSQ25)
Timepoint [10] 413007 0
Once a month for 24 months post enrolment

Eligibility
Key inclusion criteria
1. Patients who have been prescribed MC-1020 or MC-1023 for pain and/or stress.
2. Prospective participants greater than or equal to 18 years of age at the time of entry on study;
3. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
4. Prospective participants are eligible to be lawfully prescribed MC-1020 or MC-1023 by the Participating Doctor;
5. Prospective participants are able to visit their Participating Doctor’s and Participating Pharmacist’s clinics as required while being treated MC-1020 or MC-1023 and are able to provide information as required for the duration of the study;
6. Prospective participants agree to abstain from using any cannabis products other than MC-1020 or MC-1023 for the duration of their participation in the study.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prospective participants will be ineligible if they are under the age of 18 years;
2. Prospective participants will be ineligible if they are unwilling or unable to sign the Informed Consent Forms or cannot understand the Participant Information Sheet provided;
3. Prospective participants will be ineligible if they have a hypersensitivity to cannabinoids or to any of the study treatment excipients;
4. Pregnant or lactating women;
5. Prospective participants judged by the Principal Investigator to be ineligible for participation as study participants for any reason;
6. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
7. Prospective participants will be ineligible if they have concurrent medicinal or recreational cannabinoid use.

Study design
Purpose
Psychosocial
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
1/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
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] 311355 0
Commercial sector/Industry
Name [1] 311355 0
Medlab Clinical Ltd
Country [1] 311355 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical Ltd
Address
Unit 5 and 6/ 11 Lord Street
Botany, NSW, 2019
Country
Australia
Secondary sponsor category [1] 312814 0
None
Name [1] 312814 0
Address [1] 312814 0
Country [1] 312814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310847 0
National Institute of Integrative Medicine
Ethics committee address [1] 310847 0
Ethics committee country [1] 310847 0
Australia
Date submitted for ethics approval [1] 310847 0
17/05/2022
Approval date [1] 310847 0
06/09/2022
Ethics approval number [1] 310847 0
0104E_2022

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

Contacts
Principal investigator
Name 119078 0
Dr Jeremy Henson
Address 119078 0
Medlab Clinical Ltd
11-13 Lord St Botany
Building A, Unit A5 - A6, Botany Quarter
NSW, 2019, Australia
Country 119078 0
Australia
Phone 119078 0
+61 430448579
Fax 119078 0
Email 119078 0
[email protected]
Contact person for public queries
Name 119079 0
Courtney Fletcher
Address 119079 0
Medlab Clinical Ltd
11-13 Lord St Botany
Building A, Unit A5 - A6, Botany Quarter
NSW, 2019, Australia
Country 119079 0
Australia
Phone 119079 0
+61 402850414
Fax 119079 0
Email 119079 0
[email protected]
Contact person for scientific queries
Name 119080 0
Luis Vitetta
Address 119080 0
Medlab Clinical Ltd
11-13 Lord St Botany
Building A, Unit A5 - A6, Botany Quarter
NSW, 2019, Australia
Country 119080 0
Australia
Phone 119080 0
+61 403220751
Fax 119080 0
Email 119080 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
No 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.