If you’d like to book a Free 20 Min Eligibility assessment for this study, you can book here. Note: If you do book an assessment, please mention honahlee. We do not have a financial relationship with Medlab, it’s purely for record keeping purposes.
According to the TGA data, chronic pain is the number one prescribed condition for medicinal cannabis in Australia. However, while there is evidence that cannabis can benefit pain, many doctors still don’t believe in the plant’s analgesic properties. The solution to doctor scepticism is more clinical trials.
In this article, you’ll learn about a clinical study being conducted by Medlab clinical, a medicinal cannabis supplier. We were lucky to speak with the very caring and knowledgeable Courtney Fletcher, the clinical trial coordinator for Medlab clinical, about this study. In case you’d like to jump ahead, here’s an index:
- 0:26 | Background on this cannabis and chronic pain study.
- 1:35 | Why chronic pain was the focus condition for this study.
- 3:35 | Current insights from the study.
- 4:20 | Requirements for individuals who want to be a part of the study.
- 4:56 | Taking part in the study: what to expect.
- 6:15 | Cost of participation in the trial for patients.
Background on this cannabis and chronic pain study
The product used in this study is a cannabis-based medicine prescribed by a healthcare practitioner to relieve pain. The product is an oral-buccal nanoparticle spray, meaning that a spray delivers the product into the patient’s mouth. The delivery platform is called NanoCelle®, which enables faster and more effective absorption of the active ingredient into the bloodstream. In this case, the ingredients are the cannabinoids CBD and THC.
The observational study is a multicentered national study conducted in Australia. It’s for patients who are about to start therapy with the NanoCelle® cannabis-based formulation for the management of cancer related or non-cancer-related pain. During the 12 month study, Medlab will be investigating clinical and prescriptive changes of the medicine called NanaBis™.
The study commenced in May 2019, and the expected completion date is to be in May 2024. The goal is to enrol 2000 adult patients who are at least 18 years of age with a diagnosis of cancer related or non-cancer-related pain.
Why chronic pain?
Chronic pain is the most common reason for patients obtaining a script for medicinal cannabis. This is often because there are limited other methods to control chronic pain (which significantly contributes to the disease burden in about half of cancer patients).
Poor management of chronic pain can adversely affect patients’ quality of life. And, patients who do not respond well to opiates or have severe side effects from the use of traditional analgesics (pain killers) require other therapeutic options.
A study that helps learn more about treatments for chronic pain, a condition affecting 1 in 5 Australians, can significantly positively impact our community.
Current insights from the study
There is a preliminary first report. Here’re some of the important data:
- Over 900 patients enrolled
- Positive improvements in sleep
- Positive improvements in mood
- Positive improvements in activity scores
- Significant reduction in pain scores
Participant eligibility requirements
- 18+ years of age;
- Eligible to be prescribed the NanoCelle® cannabis-based formulation for the management of cancer related or non-cancer-related pain;
- Must refrain from using other cannabis products;
- Willing to participate for up to 12 months (usually around 4);
- Complete a monthly feedback/observation session;
Taking part in the study: what to expect
If you’d like to see if you’re eligible to participate in this study, you can visit Medlab’s observational study page and book a screening and eligibility assessment.
During the initial visit, the doctor will screen you to confirm your suitability for participation in the trial. The first visit is approximately 30 minutes long.
If you’re eligible and you decide to take part in the trial, you’ll need to complete two questionnaires about your pain and quality of life. You’ll be guided by the clinical team on how to complete the surveys.
Once prescribed and you’re in the study, you’ll be required to visit the clinic once a month for a maximum of 12 months (likely to be about 4 months). Each visit, you’ll provide information about the administration and efficacy of the product for managing your pain.
Cost of participation in the trial
Participants in the study will receive their Medlab cannabis product at a subsidised rate (50% off) for the duration of their participation in the study. The cost of your doctor visits, however, will be at your own expense.
After the clinical trial, if you decide to continue to use the Medlab product to manage your symptoms, the product will be purchasable at the non-subsidised price.
If you’d like to book a Free 20 Min Eligibility assessment, you can book here. Note: If you do book an assessment, please mention honahlee. We do not have a financial relationship with Medlab, it’s purely for record keeping purposes.