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Cannabinoid Medicine Observational Study (CMOS): Observation of cannabinoid prescribing and dosage patterns in Australian clinical practice

Cannabinoid Medicine Observational Study (CMOS): A prospective, open-label, observational study of cannabinoid prescribing and dosage patterns in Australian clinical practice.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000718943
Acronym
CMOS (Cannabinoid Medicine Observational Study)
Enrollment
20000
Registered
2020-07-02
Start date
2020-07-20
Completion date
2024-07-22
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is seeking to create a representative data set on the current cannabinoid prescribing and dosage patterns in Australian clinical practice for a range of health conditions including cancer. Who is it for? If you are an adult who is already receiving medicinal cannabis therapy for your health condition, or you are seeking to receive medicinal cannabis and your doctor is able to prescribe medicinal cannabis as a treatment for your health condition, you may be eligible to participate in this study. Study details Participants will be asked to complete two different online questionnaire types on alternating months for a total of 12 months while they are taking specific prescribed medicinal cannabis products under the care of a CMOS participating clinician. Each online questionnaire may take between 5 - 25 minutes to complete. It is hoped that this study will allow clinicians and researchers to better understand how medicinal cannabis products are being used in Australian clinical practice and their potential benefit/harms as measured by reporting of side effects and patient satisfaction.

Interventions

Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant). Participants will be asked to complete a total of 14 questionnaires at set time points thr

Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant). Participants will be asked to complete a total of 14 questionnaires at set time points throughout the study. The study progress questionnaire including additional validated measures of health-related quality of life, medication adherence and patient reported change will be completed at enrolment, and months 1, 3, 6, 9 and 12 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). A short-form questionnaire focused on side effect reporting, current dose and changes to other concomitant medications will be completed at months 2, 4, 5, 7, 8, 10 and 11 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). It is anticipated that each questionnaire will take between 5-30 minutes to complete, requiring a total of 30 minutes maximum participation each month for the 12 months of the study. Clinicians will be asked to complete the baseline enrolment form (10 minutes to complete) for each patient at study enrolment as well as adverse event monitoring questionnaires, each taking 5-10 minutes to complete every 3 months for the period that they have patients enrolled in the study.

Sponsors

Applied Cannabis Research
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Seeking or already receiving medicinal cannabis therapy and deemed eligible for medicinal cannabis prescription by their treating physician.

Exclusion criteria

1. Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent 2. Females who are pregnant or breastfeeding.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026