Australia-wide observational study on medical cannabis

Participants needed for a patient-centred observational study to collect data on CBD-dominant medicinal cannabis in patients with treatment-resistant conditions.

Bod Australia is conducting a nation-wide observational study to collect data on their pharmaceutical-grade, non-psychotropic, CBD-dominant medicinal cannabis oils in patients with drug-resistant conditions.

This study aims to assess the safety, tolerability and efficacy of the Bod medicines by collecting real world data from patients with treatment-resistant conditions, such as chronic pain, anxiety and mood disorders and sleep disorders, where medicinal cannabis may be appropriate.

Who is eligible to participate?

Patients who are prescribed Bod’s medicinal cannabis for any indication approved by the TGA may be eligible to participate in this study through one of the approved study sites. Eligibility for the study will be determined by medical doctors specialised in medicinal cannabis at the study sites.

Treatment with medicinal cannabis needs to be approved by the TGA on a case-by-case basis. Patients may be eligible for treatment with medicinal cannabis if they:

  • They have a chronic medical condition
  • At least two conventional approved treatment options have been trialed and found unsuitable
  • There is evidence to support the use of medicinal cannabis for the chronic condition

The TGA have approved medicinal cannabis for a number of conditions1,2, including:

  • Chronic pain
  • Anxiety disorders, including PTSD
  • Insomnia
  • Autism Spectrum Disorder (ASD)
  • Seizure management and epilepsy
  • Parkinson’s disease and tremor management
  • Palliative care
  • Dementia
  • Multiple sclerosis
  • Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS)

Since the launch of the study, there has been significant success with over 350 patients participated in the study.  The patient recruitment for this study will close end of June 2021. The Bod Clinical Team are continuing recruitment at full force to maximise participation numbers and make the most of the study.

“We are seeing interesting trends in the preliminary data and want a larger data set to improve the statistical power of our analyses and to be able to extract clinically relevant outcomes,” said Dr Adele Hosseini, Bod’s Chief Scientific Officer.

What does participation in the study involve?

Participation in the study involves periodically completing online questionnaires on health outcomes and the use of medication using the study app on your smart phone or website for the duration of the study.

Patients who participate will receive their first two bottles of medicine that are prescribed at the cost of the pharmacy dispensing fee (typically $30), and the medicines prescribed for the remainder of the study (up to 12 months) will be discounted. Clinic consultation fees apply.

The study is being conducted through nine ethics-approved clinics where medical doctors are specialised in prescribing legal medical cannabis. The clinics provide telehealth services and in-person consultations.

The data collected in this study will help support doctor confidence in prescribing these medicines, whilst also informing on dosing and clinical use.

“While randomized controlled trials (RCTs) are still required, observational studies like this one will be able to provide safety data and clinical guidance to doctors, researchers and the TGA while they are being established,” Dr Dilara Bahceci, Bod’s Science Communication Manager.

This study is running in parallel to a large-scale observational study taking place in the UK called Project Twenty21. Read about Project Twenty21’s preliminary findings and Bod’s participation in the study here.

Jo Patterson, the CEO of Bod:“Patient access to medicinal cannabis remains an issue in Australia and the UK. We want to give people who suffer from chronic and severe conditions, that haven’t had luck with conventional treatment options, the chance to try something that could really alleviate their suffering.”

Have more questions?

Book a meeting with one of Bod’s experts for free or call Bod Australia on 02 9199 5018.


Disclaimer: Please be aware that referral to these clinics will not guarantee that patients will be prescribed medicinal cannabis or be suitable to participate in the observational study. Patients should be aware that it is up to the discretion of the prescribing doctor to determine the most appropriate treatment options for a patient, which may or may not involve treatment with medicinal cannabis.

References

  1. https://www.tga.gov.au/access-medicinal-cannabis-products-1
  2. https://www.tga.gov.au/sites/default/files/foi-2250-01.xlsx