None listed
Conditions
Brief summary
Project Twenty21 Australia is an observational study which will follow patients prescribed medicinal cannabis who have been diagnosed with either chronic pain, anxiety, post-traumatic stress disorder or multiple sclerosis. They will be followed for up to 6 months. The purpose is to investigate whether medicinal cannabis products are efficacious in alleviating the symptoms associated with these conditions, and if they are safe and tolerable.
Interventions
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- th
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.
Sponsors
Releaf Training and Education trading as the Australasian College of Cannabinoid Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed