Clinical Trials

Project Twenty21 Australia- A Prospective Observational Study Investigating Medicinal Cannabis in Four Clinical Conditions

Type of Study/Intervention

Observational

Recruitment Status

Recruiting

Form of MS

Relapsing MS, Relapsing remitting MS, Secondary progressive MS, Primary progressive MS

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 12 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.

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.

Anticipated start date

Already started.

Recruitment contacts

Michelle Frans
Phone: (03) 9016 9094
Email: michelle@releafgroupltd.com

Further details

Further details can be found here.

Region

NSW, QLD, SA, WA, VIC

Ethics approval

Yes

Last updated

26/05/2022

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